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  • Daniel G. Haller, M.D., received his M.D. from the University of Pittsburgh in 1973. He completed residency training at Georgetown University, and was a Medical Oncology fellow at the same institution. After fellowship, Dr. Haller was a Senior Investigator and Head of the Medicine Section of the Clinical Investigations Branch of the National Cancer Institute. In 1980, he joined the faculty of the University of Pennsylvania, where he has been a Professor of Medicine since 1993. His chief areas of clinical research are in the management of gastrointestinal malignancies. He serves as Program Leader for Gastrointestinal Cancer for the University of Pennsylvania Cancer Center and is the Co-Chief for Clinical Affairs of the Hematology-Oncology Division. He has served as the Gastrointestinal Committee Chair for the Eastern Cooperative Oncology Group, and continues to be an active participant in the GI intergroup.
    Dr. Haller is a Fellow of the American College of Physicians, where he has served as a member of the writing panel for Medical Oncology for the MKSAP exam. He has also served as secretary to the Subspecialty Board on Medical Oncology for the American Board of Internal Medicine, and as a member of the writing committee for the first Self-Evaluation Process for Medical Oncology Recertification. He has been active in the American Society of Clinical Oncology, and has chaired the Program Committee and the Audit and Finance Committee. He is the Associate Editor for Hematology-Oncology of the Annals of Internal Medicine and has been the Editor-in-Chief of PDQ, the National Cancer Institute’s cancer information database. In May 2001, he is also assuming the role of Editor-in-Chief of the Journal of Clinical Oncology.

Transcript

  • 1. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC Combination and SequentialCombination and Sequential Chemotherapy of MetastaticChemotherapy of Metastatic Colorectal CancerColorectal Cancer Daniel G. Haller, MDDaniel G. Haller, MD University of Pennsylvania Cancer CenterUniversity of Pennsylvania Cancer Center
  • 2. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC Discussion topicsDiscussion topics • What is the goal of administeringWhat is the goal of administering combination vs sequential therapy?combination vs sequential therapy? • What is the evidence for combinationWhat is the evidence for combination versus sequential therapy?versus sequential therapy? • What are the interim endpoints inWhat are the interim endpoints in studies of sequential therapy?studies of sequential therapy? • How are new therapies incorporatedHow are new therapies incorporated into combination or sequential therapy?into combination or sequential therapy?
  • 3. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC Chemotherapy for MetastaticChemotherapy for Metastatic Colorectal CancerColorectal Cancer What is the Goal of CombinationWhat is the Goal of Combination vs Sequential Therapy?vs Sequential Therapy? – Overall survivalOverall survival • The gold standard for regulatory approvalThe gold standard for regulatory approval – Progression-free survivalProgression-free survival • Surrogate of activity for clinical trialsSurrogate of activity for clinical trials • Marker of clinical benefitMarker of clinical benefit – Response rateResponse rate – Measures of quality of lifeMeasures of quality of life • Time to symptom worseningTime to symptom worsening
  • 4. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC Chemotherapy for MetastaticChemotherapy for Metastatic Colorectal CancerColorectal Cancer Combination Chemotherapy (FU/LV WithCombination Chemotherapy (FU/LV With CPT-11 or Oxaliplatin)CPT-11 or Oxaliplatin) – RR:RR: range from 34–51%range from 34–51% – PFS:PFS: range from 6.7–9.3 mrange from 6.7–9.3 m – OS:OS: range from 14.8–19.4 mrange from 14.8–19.4 m • Statistical superiority for FU/LV/CPT-11Statistical superiority for FU/LV/CPT-11 compared to first-line FU/LVcompared to first-line FU/LV • Incremental benefit achieved without markedIncremental benefit achieved without marked increase in toxicity or negative impact on QOLincrease in toxicity or negative impact on QOL • Effects of crossover and surgical therapyEffects of crossover and surgical therapy
  • 5. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC Chemotherapy for MetastaticChemotherapy for Metastatic Colorectal CancerColorectal Cancer “There are only two tragedies in life: one is not getting what one wants, and the other is getting it.” Oscar Wilde
  • 6. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC NCCTG Trial N9741NCCTG Trial N9741 •FU/LV/CPT-11 (Saltz) weekly •FU/LV (de Gramont) + oxaliplatin Q2W •Oxaliplatin + CPT-11 Q3W -Primary endpoint: Survival -No fixed crossover; no oxaliplatin available after progression on Saltz regimen R Chemotherapy for MetastaticChemotherapy for Metastatic Colorectal CancerColorectal Cancer
  • 7. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC Chemotherapy for MetastaticChemotherapy for Metastatic Colorectal CancerColorectal Cancer FRE-C97-3: FOLFIRI vs FOLFOX • 113 patients/arm • Primary endpoint: PFS • No prior CT, >6mos from adjuvant Rx, no prior CPT-11 or oxaliplatin Oxaliplatin + de Gramont FU/LV R CPT-11 + de Gramont FU/LV Proc ASCO, abstract 949, 2000
  • 8. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC Duration of ChemotherapyDuration of Chemotherapy MRC-CR06 TrialMRC-CR06 Trial CIFU De Gramont FU/LV Tomudex R Patients are treated for 12 weeks; if stable or responding, a second randomization to 12 more weeks of therapy or discontinuation
  • 9. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC Sequence of ChemotherapySequence of Chemotherapy FOCUS TrialFOCUS Trial Modified de Gramont FU/LV CPT-11 Modified de Gramont FU/LV FU/LV+CPT-11 FU/LV/CPT-11 Modified de Gramont FU/LV FU/LV+oxaliplatin FU/LV/oxaliplatin R • 2100 patients endpoints: PFS, OS, QOL
  • 10. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC Chemotherapy for MetastaticChemotherapy for Metastatic Colorectal CancerColorectal Cancer Pivotal Trial of Oxaliplatin: EFC 4584Pivotal Trial of Oxaliplatin: EFC 4584 – Response rate in FU/LV and CPT-11Response rate in FU/LV and CPT-11 failuresfailures – Survival advantage in patients who haveSurvival advantage in patients who have failed FU/LV/irinotecanfailed FU/LV/irinotecan infusional FU/LV(de Gramont) R oxaliplatin infusional FU/LV+oxaliplatin
  • 11. D. Haller, CRC Symposium, 1.23.2001D. Haller, CRC Symposium, 1.23.2001 OncologyOncology SpectrumsSpectrums, NYC, NYC Chemotherapy for MetastaticChemotherapy for Metastatic Colorectal CancerColorectal Cancer Oxaliplatin Trials in USOxaliplatin Trials in US – EFC 4584:EFC 4584: in FU/LV/CPT-11 (Saltz)in FU/LV/CPT-11 (Saltz) failuresfailures – EFC 4585:EFC 4585: CPT-11 alone vs CPT-11 +CPT-11 alone vs CPT-11 + oxaliplatin in FU/LV failuresoxaliplatin in FU/LV failures – EFC 4759:EFC 4759: oxaliplatin in third-line therapyoxaliplatin in third-line therapy – EFC 4760:EFC 4760: de Gramont FU/LV +de Gramont FU/LV + oxaliplatin in third-line therapyoxaliplatin in third-line therapy