Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 3724
© 2005 American Society of Clinical Oncology

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Abstract

Phase II study of 5-FU/LV/Irinotecan in combination with regional hyperthermia (RHT) in 5-FU/LV refractory patients with advanced colorectal cancer

Klin Grosshadern, Munich, Germany

3724

Background: In 5FU/LV refractory pts the addition of Irinotecan as 2^nd line treatment creates response rates of 22% and leads to a progression free survival of 6.3 months (e.g. Ducreux et al. 1999). Based on the rationale that hyperthermia augments the efficacy of chemotherapeutic agents this study was undertaken to determine the therapeutic potential of a combined thermochemotherapy regimen using 5FU/LV/Irinotecan for this subgroup of pts. Methods: Between 06/01 and 03/04, 15 pts with locally advanced, not resectable (6 pts) or metastatic (9 pts) colorectal cancer were enrolled. Eligible pts had progressed under a previously given 5-FU/LV based chemotherapy. One cycle of thermochemotherapy consisted of continuous infusion of 2000 mg/m² 5-FU over 24h plus 500 mg/m² LV and 80 mg/m² Irinotecan weekly in combination with regional (RHT, 42.5°C) or part body (PBH, 40.8°C) hyperthermia for 60 minutes (endoluminal thermometry, power range 800 -1200 W, electromagnetic system BSD 2000, BSD Medical corporation, Salt Lake City, UT) for 6 weeks followed by a 2 week interval. Results: 8 male and 7 female pts (median age 62 yrs, range 34–73 yrs) received a total of 27 cycles. Response evaluation showed 2 CR (confirmed with PET scan), and 3 PR, resulting in a objective response rate of 33%. 4 of 15 pts showed PD after two cycles. After a median observation time of 15 months (9–33 months) the median time to progression was 8 months (1–28 months) and the median overall survival was 12 months (2–28 months). The major common toxicity was diarrhea (with 20% grade 3). Toxicity profile for chemotherapy was mild and manageable, except of grade 3 nausea (3 pts) and a hospitalization due to a non-neutropenic infection (1 pt). HT was well tolerated and only one patient was early withdrawn from therapy due to treatment related pain. Conclusion: The addition of HT appears not to increase the toxicity of the 5FU/LV/Irinotecan therapy. This combined approach might gain additional benefit for 5FU/LV refractory pts. The response rate is promising and warrants further investigation of hyperthermia (RHT, PBH) in a randomized trial.

No significant financial relationships to disclose.