NON-RANDOMIZED COMPARISON BETWEEN IRINOTECAN–MITOMYCIN C AND IRINOTECAN ALONE IN PATIENTS WITH ADVANCED GASTRIC CANCER REFRACTORY TO FLUOROPYRIMIDINE AND PLATINUM

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Abstract

Background

Irinotecan (CPT-11) alone and CPT-11–mitomycin C (MMC) has proven to be effective as second-line chemotherapy for advanced gastric cancer (AGC). The objective of the present study was to compare the treatment results between CPT-11 alone and combination of CPT-11 and MMC in patients (pts) with AGC refractory to fluoropyrimidine and platinum.

Methods

Between November 2006 and December 2011, 45 patients with AGC refractory to fluoropyrimidine and platinum were treated with CPT-11–MMC (arm CM, n = 22) or CPT-11 alone (arm C, n = 23) in clinical practice. CPT-11–MMC consisted of MMC 5 mg/m2 by bolus injection and irinotecan 150 mg/m2 by a 90-min infusion. In the CPT-11 alone, irinotecan 150 mg/m2 was given by a 90-min infusion. Courses were repeated every 2 weeks. The response rate was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Survival curves were generated using the Kaplan–Meier method. Adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Results

Although there were no significant difference between age, PS, histology and prior chemotherapy, male patients and number of metastatic organs were more in arm CM. The overall response rate in arm CM was 19%, and in arm C was 10.5%. The median progression-free survival was 3.8 months in arm CM versus 3.8 months in arm C. The median overall survival of arm CM versus arm C was 9.6 versus 11 months. Major grade 3/4 adverse events in arm CM versus arm C were as follows: neutropenia (45 versus 22%), anemia (36 versus 4.3%), febrile neutropenia (13 versus 13%) and anorexia (14 versus 8.7%).

Conclusions

The treatment effect of CPT-11–MMC was equivalent to CPT-11 alone in patients with AGC refractory to fluoropyrimidine and platinum. CPT-11–MMC was associated with a higher incidence of grade 3 or 4 adverse events than CPT-11 alone.

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