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ASCO 2014 update in GI cancer

This document summarizes results from several clinical trials presented at the ASCO 2014 conference on gastrointestinal oncology: - The CALGB/SWOG 80405 trial found that first-line chemotherapy with FOLFOX plus either bevacizumab or cetuximab resulted in similar progression-free and overall survival in patients with KRAS wild-type metastatic colorectal cancer. - The STORM trial found that adjuvant sorafenib after resection or ablation of hepatocellular carcinoma did not improve recurrence-free survival compared to placebo, with significant treatment-related adverse events in the sorafenib group. - The LAP 07 study evaluated the addition of radiotherapy after induction chemotherapy for

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ASCO 2014: UPDATES IN GASTROINTESTINAL ONCOLOGY Annual Updates on Breakthroughs in Hematology & Oncology (AUBHO) 2014 Kanwal Pratap Singh Raghav, MD The University of Texas M.D. Anderson Cancer Center, Houston, TX 30th August 2014
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CALGB/SWOG 80405 Alan P. Venook et al. Abstract: LBA3
CALGB/SWOG 80405 Alan P. Venook et al. Abstract: LBA3 ✤ In patients with KRAS-WT metastatic CRC where we have option of using two biologics in first line (anti-EGFR and anti-VEGF), does the choice really matter?
CALGB/SWOG 80405: OVERVIEW Phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum (MCRC). FOLFOX (73%) ✤ Primary Endpoint: OS ✤ Ho = 22 v. 27.5 m ✤ N = 1137
CALGB/SWOG 80405: RESULTS Similar PFS, Different AE/QoL (Resected disease: Median OS ~ 5.5 yr)
CALGB/SWOG 80405: PAST & PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
CALGB/SWOG 80405: PAST & PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
CALGB/SWOG 80405: PAST & PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
CALGB/SWOG 80405: PAST & PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
CALGB/SWOG 80405: PAST & PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
CALGB/SWOG 80405: PAST & PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
CALGB/SWOG 80405: PAST & PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
CALGB/SWOG 80405: PAST & PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
CALGB/SWOG 80405: PAST & PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
SWOG 80405: LESSONS LEARNED! Chemo-Bev equivalent to Chemo-Cetux in 1st-line mCRC Rx of KRAS-WT (12/13) tumors. Median OS in patient with resected mCRC ~ 5.5 yrs. ✤ ? Clinical applicability to extended RAS Mutants. ✤ ? FIRE-3: Better OS with FOLFIRI + C as 1st-line. ✤ ? PEAK: Better OS with FOLFOX + P as 1st-line. ✤ ? Sequential question unanswered (PDT rates ?). ✤ ? EPOC: Inferior PFS in resectable group. ✤ FOLFOX is preferred first line chemotherapy in the US. ✤ Future: Think ahead and homogenize population using molecular profiles.
ADORE TRIAL TAE WON KIM ET AL. (ABSTRACT 3502) In patients with rectal cancer who have received standard of care pre-operative chemoradiotherapy followed by surgery, is post-operative chemotherapy with FOLFOX better than 5FU alone in pathologic stage II/III disease in delaying recurrence? Primary Endpoint: 3-yr. DFS. ✤ Subgroup effect: Stage III & poor neoadjuvant therapy response, LVI -ve ✤ FOLFOX: BMD, Neuropathy, Fatigue
CAIRO-3 TRIAL MIRIAM KOOPMAN ET AL. (ABSTRACT 3504) In patients with metastatic CRC, after 6 cycles of CAPOX-B does maintenance therapy with Cape + Bev improve PFS? Primary Endpoint: PFS2 [Re-intro: 60% (o) v. 47% (m)]
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STORM TRIAL Jordi Bruix et al. Abstract: 4006
STORM TRIAL Jordi Bruix et al. Abstract: 4006 ✤ In patients hepatocellular cancer who have undergone resection or local ablation and are without residual disease, does adjuvant sorafenib decrease recurrence?
STORM TRIAL: OVERVIEW A phase III randomized, double-blind, placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent recurrence of hepatocellular carcinoma (HCC). Child-Pugh A/B7 (2-3% only) & ECOG PS 0 Background: 5-yr OS 50-80% (Patient selection) & Sorafenib active in metastatic setting HCC (N = 1114) No Residual Disease Sorafenib 4 years Placebo 4 years Surgery or Ablation Primary Endpoint: RFS * Sorafenib 400mg BID
STORM TRIAL: RESULTS No subgroup effect Similar OS (HR=0.99) TEAE significant (DC 25%) (Dose Δ 80%) Rx duration ~12.5 (v. 22 m)
STORM: PAST & PRESENT Meta-analysis (2001) N = 180 (3 PTs) Radical resection and IA Epi + PO Tegafur IA Epi + IV Epi IV Epi Similar OS/DFS (All Patients); Poorer OS/DFS (Cirrhosis) Surgery Adjuvant Rx Ono et al. Cancer 2001
STORM: PAST & PRESENT Meta-analysis (2001) N = 180 (3 PTs) Radical resection and IA Epi + PO Tegafur IA Epi + IV Epi IV Epi Similar OS/DFS (All Patients); Poorer OS/DFS (Cirrhosis) Surgery Adjuvant Rx Ono et al. Cancer 2001
STORM: PAST & PRESENT Meta-analysis (2001) N = 180 (3 PTs) Radical resection and IA Epi + PO Tegafur IA Epi + IV Epi IV Epi Similar OS/DFS (All Patients); Poorer OS/DFS (Cirrhosis) Surgery Adjuvant Rx Ono et al. Cancer 2001
STORM: LESSONS LEARNED! Adjuvant Sorafenib does not improve RFS in locally resected or ablated HCC. ✤ Another lesson in distinctive adjuvant & metastatic setting: ✤ ? Micro v. Macro metastatic disease & distinct biology ✤ ? Angiogenesis (Adjuvant) ✤ ? Cytostatic v. Cytocidal drug ✤ 5-yr. OS in patient with resected or ablated HCC ~ 70%. ✤ Drug toxicity profile very important in adjuvant settings. ✤ Future: Molecular characterization and biology oriented therapy and risk stratification ! Ono et al. Cancer 2001
LAP 07 STUDY Florence Huguet et al. Abstract: 4001
LAP 07 STUDY Florence Huguet et al. Abstract: 4001 ✤ In patients with locally advanced pancreatic adenocarcinoma, can use of chemoradiotherapy impact local control and time without systemic therapy?
LAP-07: OVERVIEW Impact of chemoradiotherapy (CRT) on local control and time without treatment in patients with locally advanced pancreatic cancer (LAPC) included in international phase III LAP 07 study. Primary Endpoint: OS LAPC (N = 128) R1 Gemcitabine 4 months Gemcitabine + Erlotinib No Progression R2 Cape XRT (N = 136) Same ChemoRx 2 months (N = 133) Retrospective analysis: GERCOR study: 128 patients treated with XRT or chemotherapy after induction chemotherapy (3 months). Median PFS 10.8 v. 7.4 m (P .005) and Median OS 15.0 v. 11.7 m (P .0009). Huguet et al. JCO 2007
LAP-07 TRIAL: RESULTS Toxicity profile similar (except nausea more in CRT arm) Progression site: All v. R2 (32 v. 39% local, 54 v. 52% distant) Median time to CTx reintroduction: 5.2 v. 3.2 m
LAP-07: PAST & PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
LAP-07: PAST & PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
LAP-07: PAST & PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
LAP-07: PAST & PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
LAP-07: PAST & PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
LAP-07: PAST & PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
LAP-07: PAST & PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
LAP-07: LESSONS LEARNED! Consolidation CRT after induction CTx in LAPC increases treatment free interval without improvement in overall survival. May play a role in select subset of patients with biology favoring local growth over distant metastases. ✤ ? Is LAPC truly different from metastatic disease. ✤ ? FOLFIRINOX or Gem + Abraxane alter the role of radiation. ✤ Is the duration of induction chemotherapy important to tease out biology ✤ Future: Need for effective systemic therapies and predictive biomarkers of response to both chemotherapy & radiation!
RAINBOW TRIAL Shuichi Hironaka et al. Abstract: 4005
RAINBOW TRIAL Shuichi Hironaka et al. Abstract: 4005 ✤ In patients with advanced gastric or gastroesophageal cancer refractory/intolerant to 5FU and platinum based regimen in first line does addition ramucirumab to second line therapy with paclitaxel improve survival?
RAINBOW: OVERVIEW A Global, Phase III, Randomized, Double-Blind Study of Ramucirumab Plus Paclitaxel versus Placebo Plus Paclitaxel in the Treatment of Metastatic Gastroesophageal Junction and Gastric Adenocarcinoma Following Disease Progression on First-Line Platinum- and Fluoropyrimidine-Containing Combination Therapy: Efficacy Analysis in Japanese and Western Patients. Background: AVAGAST study failed to show OS benefit from bevacizumab (median PFS & RR improved). Japanese (0lder, better PS, doublet 1st Rx, gastric): more TEAEs ! Ohtsu et al. JCO 2011; Ciombor et al. CCR 2013
RAINBOW TRIAL: RESULTS More Japanese pts (75% v. 35%) received PDT. Adjusted PDT trends same.
RAINBOW: PAST & PRESENT BSC v. Salvage ChemoRx (Docetaxel or Irinotecan): 5.3 v. 3.8 m (P = 0.007) BSC Salvage Chemotherapy: Docetaxel/Irinotecan Ramucirumab BSC II REGARD: BSC v. Ram. 5.2 v. 3.8 m (P = 0.047) New standard of care. Kang et al. JCO 2012; Fuchs et al. Lancet 2014
RAINBOW: PAST & PRESENT BSC v. Salvage ChemoRx (Docetaxel or Irinotecan): 5.3 v. 3.8 m (P = 0.007) BSC Salvage Chemotherapy: Docetaxel/Irinotecan Ramucirumab BSC II REGARD: BSC v. Ram. 5.2 v. 3.8 m (P = 0.047) New standard of care. Kang et al. JCO 2012; Fuchs et al. Lancet 2014
RAINBOW: PAST & PRESENT BSC v. Salvage ChemoRx (Docetaxel or Irinotecan): 5.3 v. 3.8 m (P = 0.007) BSC Salvage Chemotherapy: Docetaxel/Irinotecan Ramucirumab BSC II REGARD: BSC v. Ram. 5.2 v. 3.8 m (P = 0.047) New standard of care. Kang et al. JCO 2012; Fuchs et al. Lancet 2014
RAINBOW: PAST & PRESENT BSC v. Salvage ChemoRx (Docetaxel or Irinotecan): 5.3 v. 3.8 m (P = 0.007) BSC Salvage Chemotherapy: Docetaxel/Irinotecan Ramucirumab BSC II REGARD: BSC v. Ram. 5.2 v. 3.8 m (P = 0.047) New standard of care. Kang et al. JCO 2012; Fuchs et al. Lancet 2014
RAINBOW: PAST & PRESENT BSC v. Salvage ChemoRx (Docetaxel or Irinotecan): 5.3 v. 3.8 m (P = 0.007) BSC Salvage Chemotherapy: Docetaxel/Irinotecan Ramucirumab BSC II REGARD: BSC v. Ram. 5.2 v. 3.8 m (P = 0.047) New standard of care. Kang et al. JCO 2012; Fuchs et al. Lancet 2014
RAINBOW: LESSONS LEARNED! Ramucirumab + Paclitaxel improves PFS/OS in 2nd-line mG/GEJ cancers refractory to 5FU and Platinum therapy. ✤ ? Is this similar to the story of Bevacizumab (AVAGAST). ✤ ? Why 2nd-line & not 1st-line efficacy. ✤ ? Chemotherapy backbone matters. ✤ ? Validity across populations. ✤ Very heterogenous disease. ✤ Future: Biomarker analysis and comparative angiogenic efficacy! ✤ PDT can confound OS. Choice of control arm critical in studies with OS endpoint. ✤ 1st-line Ramu. + FOLFOX-6: Negative for PFS (HR 0.98). ✤ Apatinib 3rd-line study (v. BSC) (N = 273): OS benefit (HR 0.7) (P = 0.0149)
DISCUSSION

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ASCO 2014 update in GI cancer

  • 1.
    ASCO 2014: UPDATESIN GASTROINTESTINAL ONCOLOGY Annual Updates on Breakthroughs in Hematology & Oncology (AUBHO) 2014 Kanwal Pratap Singh Raghav, MD The University of Texas M.D. Anderson Cancer Center, Houston, TX 30th August 2014
  • 2.
  • 3.
    CALGB/SWOG 80405 AlanP. Venook et al. Abstract: LBA3
  • 4.
    CALGB/SWOG 80405 AlanP. Venook et al. Abstract: LBA3 ✤ In patients with KRAS-WT metastatic CRC where we have option of using two biologics in first line (anti-EGFR and anti-VEGF), does the choice really matter?
  • 5.
    CALGB/SWOG 80405: OVERVIEW Phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum (MCRC). FOLFOX (73%) ✤ Primary Endpoint: OS ✤ Ho = 22 v. 27.5 m ✤ N = 1137
  • 6.
    CALGB/SWOG 80405: RESULTS Similar PFS, Different AE/QoL (Resected disease: Median OS ~ 5.5 yr)
  • 7.
    CALGB/SWOG 80405: PAST& PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
  • 8.
    CALGB/SWOG 80405: PAST& PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
  • 9.
    CALGB/SWOG 80405: PAST& PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
  • 10.
    CALGB/SWOG 80405: PAST& PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
  • 11.
    CALGB/SWOG 80405: PAST& PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
  • 12.
    CALGB/SWOG 80405: PAST& PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
  • 13.
    CALGB/SWOG 80405: PAST& PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
  • 14.
    CALGB/SWOG 80405: PAST& PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
  • 15.
    CALGB/SWOG 80405: PAST& PRESENT GERCOR: FOLFIRI v. FOLFOX: Median OS (21.5 v. 20.6 m) (P=0.99) NO 16966: FOLFOX/ XELOX ± B: Median OS (21.3 v. 19.9m) (P=0.07) CRYSTAL: FOLFIRI ± Cetux: Median OS (23.5 v. 20m) (P<0.01) PRIME: FOLFOX ± Pan: Median OS (26 v. 20m) (P=0.04) FOLFOX FOLFIRI C + FOLFIRI FOLFIRI B + FOLFOX/XELOX FOLFOX/XELOX P + FOLFOX FOLFOX Saltz et al. JCO 2008; Tournigard et al. JCO 2004; Van Custem et al. JCO 2011; Douillard et al. NEJM 2013
  • 16.
    SWOG 80405: LESSONS LEARNED! Chemo-Bev equivalent to Chemo-Cetux in 1st-line mCRC Rx of KRAS-WT (12/13) tumors. Median OS in patient with resected mCRC ~ 5.5 yrs. ✤ ? Clinical applicability to extended RAS Mutants. ✤ ? FIRE-3: Better OS with FOLFIRI + C as 1st-line. ✤ ? PEAK: Better OS with FOLFOX + P as 1st-line. ✤ ? Sequential question unanswered (PDT rates ?). ✤ ? EPOC: Inferior PFS in resectable group. ✤ FOLFOX is preferred first line chemotherapy in the US. ✤ Future: Think ahead and homogenize population using molecular profiles.
  • 17.
    ADORE TRIAL TAEWON KIM ET AL. (ABSTRACT 3502) In patients with rectal cancer who have received standard of care pre-operative chemoradiotherapy followed by surgery, is post-operative chemotherapy with FOLFOX better than 5FU alone in pathologic stage II/III disease in delaying recurrence? Primary Endpoint: 3-yr. DFS. ✤ Subgroup effect: Stage III & poor neoadjuvant therapy response, LVI -ve ✤ FOLFOX: BMD, Neuropathy, Fatigue
  • 18.
    CAIRO-3 TRIAL MIRIAMKOOPMAN ET AL. (ABSTRACT 3504) In patients with metastatic CRC, after 6 cycles of CAPOX-B does maintenance therapy with Cape + Bev improve PFS? Primary Endpoint: PFS2 [Re-intro: 60% (o) v. 47% (m)]
  • 19.
  • 20.
    STORM TRIAL JordiBruix et al. Abstract: 4006
  • 21.
    STORM TRIAL JordiBruix et al. Abstract: 4006 ✤ In patients hepatocellular cancer who have undergone resection or local ablation and are without residual disease, does adjuvant sorafenib decrease recurrence?
  • 22.
    STORM TRIAL: OVERVIEW A phase III randomized, double-blind, placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent recurrence of hepatocellular carcinoma (HCC). Child-Pugh A/B7 (2-3% only) & ECOG PS 0 Background: 5-yr OS 50-80% (Patient selection) & Sorafenib active in metastatic setting HCC (N = 1114) No Residual Disease Sorafenib 4 years Placebo 4 years Surgery or Ablation Primary Endpoint: RFS * Sorafenib 400mg BID
  • 23.
    STORM TRIAL: RESULTS No subgroup effect Similar OS (HR=0.99) TEAE significant (DC 25%) (Dose Δ 80%) Rx duration ~12.5 (v. 22 m)
  • 24.
    STORM: PAST &PRESENT Meta-analysis (2001) N = 180 (3 PTs) Radical resection and IA Epi + PO Tegafur IA Epi + IV Epi IV Epi Similar OS/DFS (All Patients); Poorer OS/DFS (Cirrhosis) Surgery Adjuvant Rx Ono et al. Cancer 2001
  • 25.
    STORM: PAST &PRESENT Meta-analysis (2001) N = 180 (3 PTs) Radical resection and IA Epi + PO Tegafur IA Epi + IV Epi IV Epi Similar OS/DFS (All Patients); Poorer OS/DFS (Cirrhosis) Surgery Adjuvant Rx Ono et al. Cancer 2001
  • 26.
    STORM: PAST &PRESENT Meta-analysis (2001) N = 180 (3 PTs) Radical resection and IA Epi + PO Tegafur IA Epi + IV Epi IV Epi Similar OS/DFS (All Patients); Poorer OS/DFS (Cirrhosis) Surgery Adjuvant Rx Ono et al. Cancer 2001
  • 27.
    STORM: LESSONS LEARNED! Adjuvant Sorafenib does not improve RFS in locally resected or ablated HCC. ✤ Another lesson in distinctive adjuvant & metastatic setting: ✤ ? Micro v. Macro metastatic disease & distinct biology ✤ ? Angiogenesis (Adjuvant) ✤ ? Cytostatic v. Cytocidal drug ✤ 5-yr. OS in patient with resected or ablated HCC ~ 70%. ✤ Drug toxicity profile very important in adjuvant settings. ✤ Future: Molecular characterization and biology oriented therapy and risk stratification ! Ono et al. Cancer 2001
  • 28.
    LAP 07 STUDY Florence Huguet et al. Abstract: 4001
  • 29.
    LAP 07 STUDY Florence Huguet et al. Abstract: 4001 ✤ In patients with locally advanced pancreatic adenocarcinoma, can use of chemoradiotherapy impact local control and time without systemic therapy?
  • 30.
    LAP-07: OVERVIEW Impactof chemoradiotherapy (CRT) on local control and time without treatment in patients with locally advanced pancreatic cancer (LAPC) included in international phase III LAP 07 study. Primary Endpoint: OS LAPC (N = 128) R1 Gemcitabine 4 months Gemcitabine + Erlotinib No Progression R2 Cape XRT (N = 136) Same ChemoRx 2 months (N = 133) Retrospective analysis: GERCOR study: 128 patients treated with XRT or chemotherapy after induction chemotherapy (3 months). Median PFS 10.8 v. 7.4 m (P .005) and Median OS 15.0 v. 11.7 m (P .0009). Huguet et al. JCO 2007
  • 31.
    LAP-07 TRIAL: RESULTS Toxicity profile similar (except nausea more in CRT arm) Progression site: All v. R2 (32 v. 39% local, 54 v. 52% distant) Median time to CTx reintroduction: 5.2 v. 3.2 m
  • 32.
    LAP-07: PAST &PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
  • 33.
    LAP-07: PAST &PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
  • 34.
    LAP-07: PAST &PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
  • 35.
    LAP-07: PAST &PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
  • 36.
    LAP-07: PAST &PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
  • 37.
    LAP-07: PAST &PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
  • 38.
    LAP-07: PAST &PRESENT FFCD/SFRO study: Induction CRT v. Gem followed by Gem maintenance showed poorer OS (8.6 v. 13 m, P=0.03). ECOG 4201: Gem RT better OS v. Gem alone (11.1 v. 9.2 m) but higher G4/5 toxicity (41 v. 9%). CRT Arm FFCD Study CTx Arm FFCD Study CTx Arm ECOG Study CRT Arm ECOG Study Continued CTx Arm CRT Arm GERCOR Chauffert et al. Annals of Oncology 2008; Loehrer et al. JCO 2011; Huguet et al. JCO 2007 Retrospective series (N = 181): Gem-based therapy X 3 m followed by continuation or CRT (concurrent inf. FU) at investigator discretion. CRT improved median PFS (10.8 v. 7.4 m) & OS (15 v. 11.7 m).
  • 39.
    LAP-07: LESSONS LEARNED! Consolidation CRT after induction CTx in LAPC increases treatment free interval without improvement in overall survival. May play a role in select subset of patients with biology favoring local growth over distant metastases. ✤ ? Is LAPC truly different from metastatic disease. ✤ ? FOLFIRINOX or Gem + Abraxane alter the role of radiation. ✤ Is the duration of induction chemotherapy important to tease out biology ✤ Future: Need for effective systemic therapies and predictive biomarkers of response to both chemotherapy & radiation!
  • 40.
    RAINBOW TRIAL ShuichiHironaka et al. Abstract: 4005
  • 41.
    RAINBOW TRIAL ShuichiHironaka et al. Abstract: 4005 ✤ In patients with advanced gastric or gastroesophageal cancer refractory/intolerant to 5FU and platinum based regimen in first line does addition ramucirumab to second line therapy with paclitaxel improve survival?
  • 42.
    RAINBOW: OVERVIEW AGlobal, Phase III, Randomized, Double-Blind Study of Ramucirumab Plus Paclitaxel versus Placebo Plus Paclitaxel in the Treatment of Metastatic Gastroesophageal Junction and Gastric Adenocarcinoma Following Disease Progression on First-Line Platinum- and Fluoropyrimidine-Containing Combination Therapy: Efficacy Analysis in Japanese and Western Patients. Background: AVAGAST study failed to show OS benefit from bevacizumab (median PFS & RR improved). Japanese (0lder, better PS, doublet 1st Rx, gastric): more TEAEs ! Ohtsu et al. JCO 2011; Ciombor et al. CCR 2013
  • 43.
    RAINBOW TRIAL: RESULTS More Japanese pts (75% v. 35%) received PDT. Adjusted PDT trends same.
  • 44.
    RAINBOW: PAST &PRESENT BSC v. Salvage ChemoRx (Docetaxel or Irinotecan): 5.3 v. 3.8 m (P = 0.007) BSC Salvage Chemotherapy: Docetaxel/Irinotecan Ramucirumab BSC II REGARD: BSC v. Ram. 5.2 v. 3.8 m (P = 0.047) New standard of care. Kang et al. JCO 2012; Fuchs et al. Lancet 2014
  • 45.
    RAINBOW: PAST &PRESENT BSC v. Salvage ChemoRx (Docetaxel or Irinotecan): 5.3 v. 3.8 m (P = 0.007) BSC Salvage Chemotherapy: Docetaxel/Irinotecan Ramucirumab BSC II REGARD: BSC v. Ram. 5.2 v. 3.8 m (P = 0.047) New standard of care. Kang et al. JCO 2012; Fuchs et al. Lancet 2014
  • 46.
    RAINBOW: PAST &PRESENT BSC v. Salvage ChemoRx (Docetaxel or Irinotecan): 5.3 v. 3.8 m (P = 0.007) BSC Salvage Chemotherapy: Docetaxel/Irinotecan Ramucirumab BSC II REGARD: BSC v. Ram. 5.2 v. 3.8 m (P = 0.047) New standard of care. Kang et al. JCO 2012; Fuchs et al. Lancet 2014
  • 47.
    RAINBOW: PAST &PRESENT BSC v. Salvage ChemoRx (Docetaxel or Irinotecan): 5.3 v. 3.8 m (P = 0.007) BSC Salvage Chemotherapy: Docetaxel/Irinotecan Ramucirumab BSC II REGARD: BSC v. Ram. 5.2 v. 3.8 m (P = 0.047) New standard of care. Kang et al. JCO 2012; Fuchs et al. Lancet 2014
  • 48.
    RAINBOW: PAST &PRESENT BSC v. Salvage ChemoRx (Docetaxel or Irinotecan): 5.3 v. 3.8 m (P = 0.007) BSC Salvage Chemotherapy: Docetaxel/Irinotecan Ramucirumab BSC II REGARD: BSC v. Ram. 5.2 v. 3.8 m (P = 0.047) New standard of care. Kang et al. JCO 2012; Fuchs et al. Lancet 2014
  • 49.
    RAINBOW: LESSONS LEARNED! Ramucirumab + Paclitaxel improves PFS/OS in 2nd-line mG/GEJ cancers refractory to 5FU and Platinum therapy. ✤ ? Is this similar to the story of Bevacizumab (AVAGAST). ✤ ? Why 2nd-line & not 1st-line efficacy. ✤ ? Chemotherapy backbone matters. ✤ ? Validity across populations. ✤ Very heterogenous disease. ✤ Future: Biomarker analysis and comparative angiogenic efficacy! ✤ PDT can confound OS. Choice of control arm critical in studies with OS endpoint. ✤ 1st-line Ramu. + FOLFOX-6: Negative for PFS (HR 0.98). ✤ Apatinib 3rd-line study (v. BSC) (N = 273): OS benefit (HR 0.7) (P = 0.0149)
  • 50.