Phase II multi-institutional prospective trial of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer refractory to fluoropyrimidine with modified dose reduction criteria (CCOG1303)



The aim of this study was to explore the efficacy and safety of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer with modified dose reduction criteria by which the doses were manipulated earlier.


Gastric cancer patients who developed progression during the fluoropyrimidine-containing first-line chemotherapy were assigned to receive nab-paclitaxel (260 mg/m2) by triweekly administration. Dose reduction was regulated according to predefined toxicity criteria which included neutropenia less than 1000/mm3 and/or peripheral sensory neuropathy of grade 2 or more. The primary endpoint was progression-free survival.


A total of 50 patients were enrolled, 47 of whom were eligible for efficacy analyses. The median number of treatment cycles and relative dose intensity given per patient was four (range 1–25), and 90% (range 60–100). Of total administration throughout the trial of 280 cycles, dose reduction was required in 50 cycles. The median progression-free survival was 3.5 months (95% confidence interval 2.5–4.4) that met the primary endpoint. The median overall survival was 9.0 months (95% confidence interval 6.8–11.8), overall response rate was 16% (95% confidence interval 2–30), and disease control rate was 72% (95% confidence interval 54–90). The median time to treatment failure was 3.5 months (95% confidence interval 2.5–4.4). Adverse events of grade 3 or worse included neutropenia in 49%, and peripheral sensory neuropathy in 11%. Febrile neutropenia occurred only in one patient (2%).


The modified dose reduction criteria for triweekly administration of nab-paclitaxel resulted in decreased incidence of severe peripheral sensory neuropathy without decline in efficacy.

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This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Conception and design: DK, YK, Collection and assembly of data: All author, Data analysis and interpretation: DK, MA, YK, Manuscript writing: All authors, Final approval of manuscript: All authors.

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Correspondence to Daisuke Kobayashi.

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Conflict of interest

Yasuhiro Kodera has received grants and personal fees from Taiho Pharmaceutical outside the submitted work. All other authors have no relevant disclosures with regard to this paper to declare.

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All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions.

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Informed consent or substitute for it was obtained from all patients for their being included in the study.

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Kobayashi, D., Mochizuki, Y., Torii, K. et al. Phase II multi-institutional prospective trial of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer refractory to fluoropyrimidine with modified dose reduction criteria (CCOG1303). Int J Clin Oncol (2020).

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  • Gastric cancer
  • Nab-paclitaxel
  • Peripheral sensory neuropathy