Caso clinico prima linea
• Donna, 50 anni ricoverata in U.O. Pneumologia
• Fumatrice (20 sig/die da 30 anni)
• PS: 1
• Sin...
Caso clinico prima linea
• RX torace: lesioni nodulari bilaterali
• EO: linfonodo sopraclaveare destro di circa 2.0 cm
• T...
Caso clinico prima linea
• Broncoscopia con brushing e BAL: non
alterazioni della canalizzazione bilateralmente
fino al li...
Per decidere un trattamento di prima linea
più appropriato è mandatorio determinare
l’istotipo e lo stato mutazionale di E...
Caso clinico prima linea:
Risposta Quesito 1
• Asportazione linfonodo sopraclaveare destro:
adenocarcinoma con EGFR non mu...
non-squamousnon-squamous squamoussquamous
?????? ?????? ??????
NSCLCNSCLC
considerconsider
gefitinibgefitinib
EGFR mut+EGF...
EGFR-TKIs and EGFR Mutations First-Line
Randomized Phase III Studies
Study Entry Criteria and
Therapy (no.pts)
HR for PFS
...
Quale terapia di prima linea?
• Cisplatino + Pemetrexed
• Carboplatino + Paclitaxel + Bevacizumab
• Cisplatino + Gemcitabi...
non-squamousnon-squamous squamoussquamous
JMDBJMDB
HR 0.81HR 0.81
subset beva-eligiblesubset beva-eligible
ECOG HR 0.80ECO...
JMDB (ADK)* E4599 (ADK)° AVAiL (NSQ)^
(CDDP+PEM) (CBDCA+PAC+BEV) (CDDP+GEM+BEV)
OR (%)
PFS (mos)
OS (mos)
Female OS (NSQ m...
S130: Pem/CarboS130: Pem/Carbo  PemPem vs.vs. Pac/Carbo + BevPac/Carbo + Bev  BevBev
Arm B:
360
Randomized
Patients
St...
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That's cool A. Rossi caso clinico prima linea 25 settembre 2010

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That's cool A. Rossi caso clinico prima linea 25 settembre 2010

  1. 1. Caso clinico prima linea • Donna, 50 anni ricoverata in U.O. Pneumologia • Fumatrice (20 sig/die da 30 anni) • PS: 1 • Sintomi: tosse e dispnea da sforzo • Comorbidità: ipertensione ben controllata
  2. 2. Caso clinico prima linea • RX torace: lesioni nodulari bilaterali • EO: linfonodo sopraclaveare destro di circa 2.0 cm • TC Total-Body con mdc: tumefazione linfonodale sopraclaveare destra 1.7 cm. Multiple lesioni eteroplasiche polmonari periferiche bilaterali, di cui la maggiore di 3 cm al lobo inferiore di destra, linfoadenopatie mediastiniche e retrocarenali (max 3 cm) • PET total body: iperaccumulo a livello della regione sopraclaveare destra (SUV 8.9), delle multiple lesioni polmonari bilaterali (SUV max 12.5), e a livello madiastinico (SUV 10.7) cT4 N3 M1a – STADIO IV
  3. 3. Caso clinico prima linea • Broncoscopia con brushing e BAL: non alterazioni della canalizzazione bilateralmente fino al limite della visione endoscopica, in rapporto all’ubicazione periferica delle lesioni. Brushing: negativo BAL: positivo per carcinoma NOS
  4. 4. Per decidere un trattamento di prima linea più appropriato è mandatorio determinare l’istotipo e lo stato mutazionale di EGFR. E’ necessario: • asportare il linfonodo sopraclaveare destro oppure • effettuare un ago aspirato dello stesso oppure • ripetere la broncoscopia con il tentativo di un agobiopsia transbronchiale? Caso clinico prima linea: Quesito 1
  5. 5. Caso clinico prima linea: Risposta Quesito 1 • Asportazione linfonodo sopraclaveare destro: adenocarcinoma con EGFR non mutato
  6. 6. non-squamousnon-squamous squamoussquamous ?????? ?????? ?????? NSCLCNSCLC considerconsider gefitinibgefitinib EGFR mut+EGFR mut+ First-line approach in advanced NSCLC EGFR wt or unknownEGFR wt or unknown
  7. 7. EGFR-TKIs and EGFR Mutations First-Line Randomized Phase III Studies Study Entry Criteria and Therapy (no.pts) HR for PFS (EGFR mut +) HR for OS (EGFR mut +) IPASS Mok NEJM 2009 Asiatic, never- & light – smokers, adenocarcinoma (EGFR mut + 59.7%) GEF (609) vs. CBDCA+PAC (608) 0.48 (0.36-0.66) 0.91 * (0.76-1.10) *overall population First – SIGNAL Proc. IASLC 2009 Adenocarcinoma, Never- smokers (EGFR mut + 44%) GEF (159) vs. CDDP+GEM (150) 0.61 (0.30-1.22) 0.82 (0.35-1.92) NEJ002 Maemondo NEJM 2010 EGFR Mutation + (all) GEF (98) vs. CBDCA+PAC (96) 0.30 (0.22-0.41) GEF 30.5 mos CT 23.6 mos P = 0.31 WJTOG3405 Mitsudomi Lancet Oncol 2010 EGFR Mutation + (all) GEF (86) vs. CDDP+DOC (86) 0.49 (0.34-0.71) NA EURTAC (EU) EGFR Mutation + (all) ERL vs. Platinum-based chemo ? ongoing ? ongoing
  8. 8. Quale terapia di prima linea? • Cisplatino + Pemetrexed • Carboplatino + Paclitaxel + Bevacizumab • Cisplatino + Gemcitabina + Bevacizumab Caso clinico prima linea: Quesito 2
  9. 9. non-squamousnon-squamous squamoussquamous JMDBJMDB HR 0.81HR 0.81 subset beva-eligiblesubset beva-eligible ECOG HR 0.80ECOG HR 0.80 AVAiL HR 0.98AVAiL HR 0.98 cisplatin-cisplatin- pemetrexedpemetrexed doublet +doublet + bevacizumabbevacizumab platinumplatinum doubletdoublet NSCLCNSCLC considerconsider gefitinibgefitinib EGFR mut+EGFR mut+ *Beva-eligible:*Beva-eligible: non-squamous, no grnon-squamous, no gr ≥≥2 haemoptysis, no invasion of major vessels,2 haemoptysis, no invasion of major vessels, no cavitation, no uncontrolled hypertension, no recent history of thrombosis,no cavitation, no uncontrolled hypertension, no recent history of thrombosis, no hemorrhagic disorders, no recent anticoagulationno hemorrhagic disorders, no recent anticoagulation First-line approach in advanced NSCLC EGFR wt or unknownEGFR wt or unknown
  10. 10. JMDB (ADK)* E4599 (ADK)° AVAiL (NSQ)^ (CDDP+PEM) (CBDCA+PAC+BEV) (CDDP+GEM+BEV) OR (%) PFS (mos) OS (mos) Female OS (NSQ mos) G3/4 Toxicity (%) (NSQ) Neutropenia FN PLT Hypertension Any G Alopecia Outcomes in Adenocarcinoma histology 31.9 35 34.6-37.8 5.5 6.6 6.5-6.7 12.6 14.2 13.4-13.6 13.8 13.3 NR 15.1 25.5 36-40 1.3 5.2 2.0 4.1 1.6 23-27 NR 7.0 6-9 11.9 NR NR52% (Scagliotti JCO 2002) 10% *Scagliotti JCO 2008; Scagliotti Oncologist 2009 °Sandler NEJM 2006; Sandler JTO 2010 ^Reck JCO 2009; Reck Ann Oncol 2010
  11. 11. S130: Pem/CarboS130: Pem/Carbo  PemPem vs.vs. Pac/Carbo + BevPac/Carbo + Bev  BevBev Arm B: 360 Randomized Patients Stratification factors: •Disease stage • Performance status •Gender R A N D O M I Z E Pemetrexed 500 mg/m2 Carboplatin AUC 6 q 21 days X 4 cycles* Paclitaxel 200 mg/m2 Carboplatin AUC 6 Bevacizumab 15 mg/kg q 21 days X 4 cycles* Arm A: Pemetrexed 500 mg/m2 q 21 days until PD or treatment discontinuation Bevacizumab 15 mg/kg q 21 days until PD or treatment discontinuation *In both treatment arms, patients with CR, PR, or SD after 4 cycles of induction therapy continue on to maintenance therapy. Induction Therapy Maintenance Therapy Zinner R, Saxman S, Peng G, et al. Randomized, Open-Label Study of Pemetrexed/Carboplatin Followed by Maintenance Pemetrexed Versus Paclitaxel/Carboplatin/Bevacizumab Followed by Maintenance Bevacizumab in Patients With Advanced Non- Small Cell Lung Cancer (NSCLC) of Nonsquamous Histology. ASCO - Chicago, IL, Jun 4-8, 2010 – JCO 28, abstr. TPS290. Primary endpoint: PFS without G4 toxicity, HR=0.75, N=360

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