Final analysis of a multicenter, randomized phase II trial comparing three different chemoradiotherapy regimens in the treatment

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2009 ASCO Annual Meeting

Abstract No: 4610 Citation:

J Clin Oncol 27:15s, 2009 (suppl; abstr 4610)
R. Wilkowski,
S. Boeck, S. Ostermaier, R. Sauer, M. Herbst, R. Fietkau, M. Flentje,
C. J. Bruns, H. G. Rau, V. Heinemann; Klinik Bad Trissl, Oberaudorf,
Germany; Klinikum Grosshadern, University of Munich, Munich, Germany;
University of Erlangen, Erlangen, Germany; University of Regensburg,
Regensburg, Germany; University of Rostock, Rostock, Germany;
University of Würzburg, Würzburg, Germany; Klinikum Dachau, Dachau,
Background: To
date, no standard treatment approach for patients (pts) with
non-resectable, locally advanced pancreatic cancer (PC) is defined.
Within a prospective phase II trial treatment-naive pts with locally
advanced PC and adequate organ function were randomly assigned to three
different CRT regimens; all pts received a conventionally fractionated
radiotherapy of 50 Gy (with a daily dose of 2.0 Gy) and were randomized
to either concurrent 5-FU as a 24h-infusion (350 mg/m²/d on each day of
radiotherapy, RT-5FU arm), concurrent low-dose gemcitabine 300 mg/m²
and cisplatin 30 mg/m² on days 1, 8, 22, and 29 (RT-GC arm), or the
same concurrent treatment followed by a sequential chemotherapy with
full- dose gemcitabine (1000 mg/m²) and cisplatin (50 mg/m²) every two
weeks (RT-GC+GC arm). Treatment duration in the RT- GC+GC arm was upon
disease progression or unacceptable toxicity. The primary study
endpoint was the overall survival (OS) rate after 9 months (mo);
secondary endpoints included response rate (WHO criteria),
progression-free survival (PFS), resectability and toxicity.
Ninety-five patients (median age 64 years, 54% male, 50% KPS 90-100%)
were recruited from 12 German centers. Seventy patients were evaluable
for objective response: the intent-to-treat response rate (CR+PR) was
19% in the RT-5FU arm, 22% in the RT-GC arm and 13% in the RT-GC+GC
arm, respectively. Overall, 18 pts (19%) underwent surgical resection
after initial CRT (R0 in 8 pts). After a median follow-up of 8.6 mo,
median PFS was estimated with 4 mo (RT-5FU), 5.6 mo (RT-GC) and 6 mo
(RT- GC+GC), respectively (p=0.21). The corresponding median OS times
were 9.6 mo, 9.3 mo and 7.3 mo (p=0.61). Hematological grade 3/4
toxicities were higher in the two gemcitabine/cisplatin-containing
arms, but no grade 3/4 febrile neutopenia was observed. Regarding
non-hematological toxicity, nausea/vomiting were more frequently in the
RT-GC and RT-GC+GC arm, whereas diarrhea was more frequent in the
RT-5FU arm.
Conclusions: Based on these data,
gemcitabine/cisplatin-based CRT does not achieve a higher clinical
efficacy compared to RT-5FU, and is associated with increased
hematological toxicity.