Long-term follow-up of efficacy of irinotecan-based chemotherapy in poor-risk patients suffering from metastatic colorectal cancer.

Abstract

e14102 Background: Irinotecan (CPT11)-based chemotherapy has provided a significant advancement in the management of patients with metastatic colorectal cancer (MCRC). However, some previous data indicated that patients with poor PS, prior adjuvant chemotherapy and high tumor burden at diagnosis might not benefit from longer survival with CPT11-based chemotherapy. To evaluate whether CPT11-based chemotherapy could be suitable for poor-risk MCRC, we performed a retrospective analysis. Methods: Out of 197 CRC patients treated in our department between 2002-2009, 53 poor risk MCRC patients (poor-risk group was defined as ≥ 2 criteria being fulfilled, i.e. PS > 1, and/or elevated serum LDH, and/or > 1 metastatic site, and/or prior adjuvant chemotherapy) were chosen for the analysis and the results were compared (retrospectively) to respective standard risk MCRC cases. The poor-risk arm included 17 females and 36 males, age between 40- 81 (median 64.7). All the patients were treated with first-line irinotecan-based chemotherapy, according to either de Gramont or AIO regimen. Results: In the analyzed poor-risk group the confirmed RR (CR + PR) was 21.3% what was lower than in the standard-risk group (RR = 50%, p < 0.05). The poor risk group median TTP was 7.1 months, median PFS was 7.3 months, and median OS 15 months. The standard-risk group median TTP, PFS and OS were not statistically different from the poor-risk group (9.3 mts, 9.9 mts, and 16 mts respectively). All the patients received second-line chemotherapy, including biologic agents. CPT11-based chemotherapy was safe. No grade (G) 4 toxicity was observed. The most common adverse events (AE) were diarrhea (28.3% – 15 pts) and neutropenia (11.3% – 6 pts), but G3 AE were noted only in three and two persons respectively. Conclusions: Our analysis showed, that irinotecan-based chemotherapy was an effective and safe treatment option even for poor-risk patients suffering from MCRC. Although the RR was lower in comparison to standard-risk cases it did not translate into significantly shorter TTP and PFS. Subsequent lines of chemotherapy affected the overall survival. Thus, poor-risk status did not preclude irinotecan-based chemotherapy. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche Pfizer, Roche, sanofi-aventis