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Phase II clinical trial of induction chemotherapy with fixed dose rate gemcitabine and cisplatin followed by concurrent chemoradiotherapy with capecitabine for locally advanced pancreatic cancer

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Abstract

Purpose

5-FU-based concurrent chemoradiotherapy (CRT) has been the mainstay of treatment for locally advanced pancreatic cancer (LAPC) for the past decades, but the prognosis remains dismal.

Methods

Patients with pathologically confirmed LAPC of the pancreas, an ECOG PS of 0–2 and no prior chemo- or radiotherapy were eligible. The treatment consisted of induction (IND) chemotherapy with a fixed dose rate gemcitabine 1,000 mg/m² on days 1 and 8 and CDDP 60 mg/m² on day 1 every 3 weeks for 3 cycles. Subsequently, the patients without progression received CRT of 55.8 Gy/31 fractions with capecitabine 650 mg/m² twice daily. Gemcitabine was given for 3 cycles after CRT. The primary endpoint was time to progression.

Results

Thirty-seven patients with LAPC were enrolled. Median age was 55 years, there were 20 males and 17 females, and ECOG PS was 0 in 6 and 1 in 31. Three patients (9.7 %) achieved partial responses after IND chemotherapy. Twenty-five patients received CRT with a mean radiation dose of 54.0 Gy, with one additional patient achieving a partial response. The median time to progression was 7.2 months (95 % CI, 4.4–10), and the median overall survival was 16.8 months (95 % CI, 12.9–20.7). The grade 3/4 toxicities included neutropenia (29 %/6.5 %), thrombocytopenia (3.2 %/0 %) and anemia (9.7 %/0 %) during the IND phase and grade 3 neutropenia and diarrhea occurring in one and two patients during CRT phase.

Conclusions

IND chemotherapy with gemcitabine and cisplatin followed by CRT with capecitabine and maintenance gemcitabine was well tolerated and exhibited promising efficacy for the treatment of LAPC.

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Authors and Affiliations

  1. Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea

    Seock-Ah Im, Tae-You Kim, Yung-Jue Bang & Yong Bum Yoon

  2. Department of Internal Medicine, Inha University Hospital, Incheon, Korea

    Joo Han Lim

  3. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

    Jee Hyun Kim & Jin-Hyeok Hwang

  4. Department of Radiation Oncology, Seoul National University Hospital, Seoul, Korea

    Eui Kyu Chie & Sung Whan Ha

  5. Department of Radiation Oncology, Seoul National University Bundang Hospital, Seongnam, Korea

    Jae-Sung Kim

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  1. Jae-Sung Kim
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Correspondence to Yung-Jue Bang or Yong Bum Yoon.

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Jae-Sung Kim and Joo Han Lim contributed equally to this work.

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Kim, JS., Lim, J.H., Kim, J.H. et al. Phase II clinical trial of induction chemotherapy with fixed dose rate gemcitabine and cisplatin followed by concurrent chemoradiotherapy with capecitabine for locally advanced pancreatic cancer. Cancer Chemother Pharmacol 70, 381–389 (2012). https://doi.org/10.1007/s00280-012-1918-7

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