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Annals of Oncology 12:187-191, 2001
© 2001 European Society for Medical Oncology

research-article

Use of the ratio of time to progression following first-and second-line therapy to document the activity of the combination of oxaliplatin with 5-fluorouracil in the treatment of colorectal carcinoma

A. Bonetti1,, M. Zaninelli1, R. Leone2, T. Franceschi1, A. P. Fraccon1, F. Pasini1, R. Sabbioni1, G. L. Cetto1, D. Sich3, S. Brienza3 and S. B. Howell4

1Departments of Oncology
2Departments of Pharmacology, Azienda Ospedahera and University of Verona Verona, ltaly
3Debioclinic France SA, Paris, France
4Department of Medicine and the cancer Center, University of California San Diego Cancer Center USA

Department of Oncology Azienda Ospedaliera di Verona P.le Stefani I 37126 Verona Italyabonetti{at}sfm.univr.it

BACKGROUND:: It has been proposed that the activity of a second-line treatment regimen can be documented by showing that the time to progression (TTP) following second-line therapy is longer than the TTP following first-line therapy in the same patients.

PATIENTS AND METHODS:: The ratio of TTP during first and second-line therapy, identified as the growth modulation index (GMI), was determined in 34 patients with advanced colorectal cancer. First-line chemotherapy consisted of one of several schedules of leucovorin (LV)-modulated 5-fluorouracil (5-FU) or raltitrexed. Second-line therapy consisted of the combination of LV-rnodulated 5-FU and oxaliplatin (l-OHP). Patients were switched to second-line therapy upon evidence of progressive disease following first-line therapy.

RESULTS:: Median TTP following first-line therapy was 13 weeks (95% confidence interval (CI): 7.6–18.7), while median TTP following second-line therapy was 31 weeks (95% CI: 2 1.3–41.0). Sixteen patients (47%; 95% CI: 35%–59%), showed a GMI ≥ 1.33, while the remaining 18 patients (53%; 95% CI: 40%–66%) had a GMI < 1.33. Log-rank analysis of the Kaplan–Meier curves of TTP following first-versus second-line therapy demonstrated a statistically significant difference in favour of second-line therapy (P = 0.0081).

CONCLUSIONS:: This study demonstrates the utility of the GMI as a tool for assessing the activity of novel second-line therapeutic programs.

5-fluorouracil, advanced colorectal cancer, growth modulation index, oxaliplatin


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