New drugs for colorectal cancer (irinotecan, oxaliplatin, raltitrexed) meet expectations in routine practice: a single center's experience before and after their introduction.

Background and aims: Treatment of metastatic colorectal cancer with new drugs (NDs) as oxaliplatin and irinotecan had improved response and survival. In order to check whether the promising achievements of the trials are obtained in routine clinical practice, we have reviewed retrospectively our results for two periods, before (period A: 1993-1995, n=63) and after (period B:1998-2000 n=103) the introduction of these NDs. Patients characteristics, treatment modalities, survival, and prognostic factors were compared.

Patients: There were 74 women and 92 men, aged 60.8+/-11.6 yr, 7 patients received best supportive care only, 91 had synchronous metastasis.

Results: Period B patients were older, with WHO score>1 more often, more adjuvant treatment, more metachronous metastasis, and NDs used more frequently (24% vs 59%). Median survival was similar (16 vs 15 mo). But when looking at the population aged<75 years with WHO score<2, median survival was 13 mo (period A) vs 21 mo (period B); survival at 1, 2, and 3 yr were respectively 59.5+/-8%, 16.2+/-6 %, 13.5+/-6 % vs 69.8+/-6%, 49.6+/-7%, 29.8+/-7%, p<0.01). In multiparametric analysis, factors correlated with survival were the absence of elevated serum alkaline phosphatase, a unique metastatic organ, and administration of NDs.

Conclusion: In our routine clinical experience the use of NDs for metastatic CRC has allowed a significant improvement in survival among patients with unresectable tumors.