Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 4635
© 2008 American Society of Clinical Oncology

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Abstract

Regional hyperthermia (RHT) combined with gemcitabine (GEM) + cisplatin (CIS) in patients with GEM-refractory advanced pancreatic cancer: Results of the ESHO phase II trial

University of Munich, Munich, Germany; Argirov Klinik Starnbergersee, Munich, Germany; Hämato-onkologische Schwerpunktpraxis Tagesklinik, Munich, Germany

4635

Background: Our recent meta-analysis of 1st-line GEM when combined with CIS or analogs indicated a significant benefit compared to GEM alone in advanced pancreatic cancer (ASCO 2007: 4515). Based on chemosensitization of CIS by RHT we performed a prospective single-center phase II trial with GEM+CIS combined with RHT under the guidance of ESHO (European Society of Hyperthermic Oncology). Methods: 22 pts with metastatic (n=19) or locally advanced (n=3) pancreatic cancer and disease progression after GEM- based 1st-line chemotherapy were eligible. Primary endpoint: TTP2 (progression free survival = start of 2nd-line therapy until progression of disease or death). Secondary endpoints: best clinical response; OS. Treatment: GEM (1,000 mg/m²) day 1 and CIS (25 mg/m²) plus RHT days 2 and 4, biweekly x4. Response evaluation was performed by CT scans. A target PFS 4 mo in 30% of all pts. corresponding to a median TTP2 2.3 mo was anticipated. For evaluation of GEM+CIS+RHT efficacy the rate [95% CI] of pts. with TTP2 4 mo was assessed. Results: 22 pts were enrolled until 11/2007 with median follow-up of 14.2 mo. Pt characteristics: median age 59 yrs; WHO-PS: 1(55%); 2(45%). Except grade 3 anemia (3 pts) only grade 1 or 2 toxicities occurred. Grade 2 toxicities included anemia (59%), leukopenia (32%), neutropenia (18%; with fever 9%), thrombopenia (5%), metabolic toxicity (9%) and nausea/vomiting (68%), respectively. Median TTP1 was 5.6 mo (CI: 3.6–8.8) and median TTP2 was 4.2 mo (CI: 2.1–7.7). The target TTP2 of 4 mo was reached in 12/22 pts. (54.6%; CI: 32.2–75.6). For secondary endpoints: best clinical response (20/22 pts evaluable) was 45% (1 CR, 1 PR, 8 SD). Median OS was 16.9 mo (CI: 11.8–22.0). Conclusions: GEM+CIS combined with RHT as 2nd-line treatment shows significant antitumor activity even in GEM refractory pancreatic cancer with tolerable toxicity. Based upon these data a prospective randomized 1st-line phase III clinical trial has been initiated. Supported by ESHO and Helmholtz Center Munich.

No significant financial relationships to disclose.

Abstract presentation from the 2008 ASCO Annual Meeting