A phase I study of neoadjuvant chemotherapy with gemcitabine plus oral S-1 for resectable pancreatic cancer

  • Authors:
    • Hidehiro Tajima
    • Hirohisa Kitagawa
    • Tomoya Tsukada
    • Shinich Nakanuma
    • Koichi Okamoto
    • Seisho Sakai
    • Isamu Makino
    • Hiroyuki Furukawa
    • Keishi Nakamura
    • Hironori Hayashi
    • Katsunobu Oyama
    • Masafumi Inokuchi
    • Hisatoshi Nakagawara
    • Tomoharu Miyashita
    • Hideto Fujita
    • Hiroshi Itoh
    • Hiroyuki Takamura
    • Itasu Ninomiya
    • Sachio Fushida
    • Takashi Fujimura
    • Tetsuo Ohta
  • View Affiliations

  • Published online on: May 27, 2013     https://doi.org/10.3892/mco.2013.133
  • Pages: 768-772
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Abstract

The aim of this study was to determine the maximum‑tolerated dose (MTD), the dose-limiting toxicity (DLT) and the recommended dose (RD) of neoadjuvant chemotherapy (NAC) with gemcitabine (GEM) plus oral S-1 in patients with resectable pancreatic cancer. Thirteen patients with radiologically proven resectable pancreatic cancer were included in this study. S-1 was administered orally for 14 consecutive days, and GEM was administered on days 8 and 15 for two pre‑operative cycles. The dose of S-1 in this study was planned with fixed doses of GEM (1,000 mg/m2): 20, 30 and 40 mg/day for levels 0, 1 and 2, respectively. Treatment was initiated at level 1 in 3 patients, while adverse events occurred in 2 patients during the second course, leading to a dose reduction to level 0 for the 8 remaining patients. Two of the 10 patients enrolled at level 0 were excluded. Of the remaining 8 patients, GEM administration was terminated due to DLT on day 15, during the first course in 3 patients, while level 0 dosage reached MTD. Surgery was performed for the remaining 11 patients included in the study. Post‑operative complications included pancreatic fistulas in 5 patients and Pseudomonas aeruginosa sepsis in 1 patient. Two of the 11 patients exhibited a partial response and 9 patients stable disease. Eight of the 11 tumor specimens showed histopathological evidence of tumor cell injury. In conclusion, NAC with GEM and S-1 was not well‑tolerated in this study. However, pre‑operative chemotherapy may be effective against pancreatic cancer. Therefore, it is necessary to reconsider NAC regimens for pancreatic cancer.
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July 2013
Volume 1 Issue 4

Print ISSN: 2049-9450
Online ISSN:2049-9469

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APA
Tajima, H., Kitagawa, H., Tsukada, T., Nakanuma, S., Okamoto, K., Sakai, S. ... Ohta, T. (2013). A phase I study of neoadjuvant chemotherapy with gemcitabine plus oral S-1 for resectable pancreatic cancer. Molecular and Clinical Oncology, 1, 768-772. https://doi.org/10.3892/mco.2013.133
MLA
Tajima, H., Kitagawa, H., Tsukada, T., Nakanuma, S., Okamoto, K., Sakai, S., Makino, I., Furukawa, H., Nakamura, K., Hayashi, H., Oyama, K., Inokuchi, M., Nakagawara, H., Miyashita, T., Fujita, H., Itoh, H., Takamura, H., Ninomiya, I., Fushida, S., Fujimura, T., Ohta, T."A phase I study of neoadjuvant chemotherapy with gemcitabine plus oral S-1 for resectable pancreatic cancer". Molecular and Clinical Oncology 1.4 (2013): 768-772.
Chicago
Tajima, H., Kitagawa, H., Tsukada, T., Nakanuma, S., Okamoto, K., Sakai, S., Makino, I., Furukawa, H., Nakamura, K., Hayashi, H., Oyama, K., Inokuchi, M., Nakagawara, H., Miyashita, T., Fujita, H., Itoh, H., Takamura, H., Ninomiya, I., Fushida, S., Fujimura, T., Ohta, T."A phase I study of neoadjuvant chemotherapy with gemcitabine plus oral S-1 for resectable pancreatic cancer". Molecular and Clinical Oncology 1, no. 4 (2013): 768-772. https://doi.org/10.3892/mco.2013.133