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Reviewer: Dr Scott Berry Date posted: June 21, 2007

OPTIMOX2, a large randomized phase II study of maintenance therapy or chemotherapy-free intervals (CFI) after FOLFOX in patients with metastatic colorectal cancer (MRC). A GERCOR study. Reviewer: Dr Scott Berry Date posted: June 21, 2007. Rationale.

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Reviewer: Dr Scott Berry Date posted: June 21, 2007

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  1. OPTIMOX2, a large randomized phase II study of maintenance therapy or chemotherapy-free intervals (CFI) after FOLFOX in patients with metastatic colorectal cancer (MRC). A GERCOR study. Reviewer: Dr Scott Berry Date posted: June 21, 2007

  2. Rationale • The OPTIMOX1 trial randomized patients with metastatic colon cancer who had received 3 months of FOLFOX induction therapy to • continued FOLFOX • vs q 2 weekly infusional 5FULV maintenance with re-introduction of FOLFOX when tumours had progressed beyond their baseline size

  3. Rationale • The OPTIMOX 1 trial demonstrated that the FULV maintenance strategy generally reduced toxicities but did not reduce survival (Tournigand JCO 2006) • OPTIMOX 2 was designed to see whether the 5FULV maintenance could be omitted in favour of a “chemotherapy free interval” after FOLFOX induction

  4. Rationale • The OPTIMOX 1 trial introduced the concept of Duration of Disease Control: J Clin Oncol 24:394-400, 2006 by American Society of Clinical Oncology

  5. N=200 Primary Outcome: OS OPTIMOX 1: mFOLFOX7 x 6 cy 5FULV maintenance until progression Then FOLFOX7 reintroduction R OPTIMOX 2: mFOLFOX7 x 6 cy No maintenance until progression Then FOLFOX7 reintroduction Untreated Metastatic Colon Cancer

  6. RESULTS

  7. STUDY COMMENTARY • The OPTIMOX2 strategy of 3 month induction chemo followed by a chemo free interval results in a clinically significant (borderline statistical significance) detriment in overall survival • Why? • ? Longer induction • ? Shorter break before re-introduction • Labianca - ASCO 2006 • Intermittent FOLFIRI 2 mos on / 2 mos off vs Continuous FOLFIRI demonstrated equivalent survival • ? Different maintenance strategy • DREAM (OPTIMOX3) - Bevacizumab/Erlotonib vs Bevacizumab maintenance after FOLFOX+Bev induction

  8. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • The current variable availability of oxaliplatin as first line therapy for metastatic colon cancer likely limits the use of an “OPTIMOX” strategy • For Canadian oncologists contemplating an induction maintenance strategy after 3 months of FOLFOX chemotherapy, the 5FULV component of therapy should be continued as maintenance therapy after induction • Other intermittent chemotherapy strategies such as that reported by Labianca at ASCO 2006 have decreased exposure to chemo without a detriment in survival

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