PHASE II STUDY ALTERNATING MFOLFOX 6 AND FOLFIRI (FIREFOX) PLUS BEVACIZUMAB (BEV) REGIMEN IN FIRST-LINE TREATMENT OF ADVANCED COLORECTAL CANCER IN JAPANESE PATIENTS (KSCC 0801)

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Abstract

Background

The Kyushu Study group of Clinical Cancer conducted a phase II study that evaluated the FIREFOX regimen. (KSCC0701, Akagi et al., J Clin Oncol 28:15s, 2010). This study demonstrated the efficacy and mild neurotoxicity of this regimen. The present study evaluated the efficacy and safety of the FIREFOX plus bevacizumab (bev).

Methods

Eligibility criteria included histologically confirmed advanced colorectal cancer, ECOG PS 0-2 and adequate bone marrow, renal and hepatic function. Patients received an alternating regimen of four cycles of mFOLFOX-6 plus bev (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, bev 5 mg/kg d1 followed by 400 mg/m2 bolus 5-FU and a 46-h 2400 mg/m2 5-FU infusion every 2 weeks) followed by four cycles of FOLFIRI plus bev (oxaliplatin replaced with irinotecan 150 mg/m2 d1). This schedule was repeated until unacceptable toxicity or disease progression occurred. The primary end point is progression-free survival. (UMIN000001312.)

Results

Of the 52 patients enrolled from May 2008 to July 2009. Two of the patients did not fulfill the eligibility criteria. M/F, 30/20; median age, 59.5 years (range 37–75); ECOG PS 0/1/2, 46/4/0. The median number of administration cycles was 14 (range, 2–44). Response rate (RECIST criteria) for CR, PR, SD, PD and NE were 2 (4%), 28 (56%), 14 (28%), 4 (8%) and 2 (4%), respectively. An overall response rate was 60% (95% CI: 45%–74%). Median progression-free survival was14.2 M (95% CI: 10.6 M–16.3 M) and median overall survival was 27.5 M (95% CI; 22.4 M; not determined). The 2-year survival rate was 56.8%. Of the 52 patients evaluated for toxicity. The most common grade 3–4 adverse events were leukopenia (7.7%), neutropenia (32.7%), anemia (1.9%), fatigue (9.6%), anorexia (13.5%), stomatitis (3.8%), neurotoxicity (3.8%), hypertension (1.9%), diarrhea (7.7%), febrile neutropenia (3.8%), nausea (9.6%), vomiting (5.8%), hypersensitivity (3.8%), and thromboembolism (1.9%).

Conclusions

The results of this phase II study show that the FIREFOX plus bev regimen is effective and well tolerated in the first-line treatment of advanced colorectal cancer. The low rate of neurotoxicity is also promising.

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