Abstract
e14524 Background: There is ongoing debate on the treatment benefit of gemcitabine (G) plus cisplatin (CIS) compared to G alone in firstline treatment of APC. However, from preclinical research it is proven that cytotoxicity of both drugs – G and CIS – is enhanced by heat exposure at 40 to 42°C. Here we show first clinical data on the combination of G plus CIS with RHT (Tmax 42°C) as secondline treatment in APC patients with G-refractory disease. Methods: Pts with locally advanced (n=2) or metastatic (n=21) pancreatic cancer with relapse after G firstline chemotherapy were retrospectively analysed. Pts received 8 cycles of G (1,000mg/m2) on day 1 and CIS (25mg/m2) combined with RHT (Tmax: 42°C) using the BSD -2000 hyperthermia system (BSD Medical Corporation, Salt Lake City, UT, USA) on days 2 + 4, biweekly according to an institutional protocol (nr. 79/98). CT scans were performed after 4, 8 and every 2 months thereafter. For endpoints we analysed toxicity and progression free survival (TTP2 defined as time from start of second-line therapy until progression of disease or death; [primary]) and overall survival and best clinical response (secondary). TTP1 was defined as time from start first-line therapy until progression of disease. Results: Between 10/99 and 08/08 overall 23 pts received a median of 5 G+CIS with RHT cycles (range 1-12). Pt characteristics: male 74%, female 26%; median age 60 yrs; majority of pts (n= 17) had ECOG 0/1 (74 %). Hematological toxicity grade 3/4 (NCI toxicity criteria): no grade 4 toxicity, grade 3 anemia (n=6), grade 3 leucopenia (n=3). Hyperthermia-associated toxicity: discomfort (n=5), power-related pain (n=13), position-related pain (n=15). Best clinical response (CR+PR+SD): 50% (16/23 pts evaluable; 0 CR, 1 PR, 7 SD). Median TTP1 was 5.9 mts (95% CI: 2.6-9.2), median TTP2 was 4,3 mts (95% CI: 1.2-7.4) and OS was 12.9 mts (95% CI: 9.9-15.9). Conclusions: G plus CIS with RHT is clinically active in G-pre-treated APC, with an acceptable safety profile. A prospective controlled phase II clinical trial of G+CIS+ RHT (EudraCT: 2005-003855-11) using this setting is currently recruiting.
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