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PR017/#434  A phase II study of oxaliplatin with oral S-1 for patients with recurrent non-squamous cell carcinoma of uterine cervix (Tohoku gynecologic cancer unit 206 study)
  1. Takayuki Nagasawa1,
  2. Tadahiro Shoji1,
  3. Shingo Hosomi1,
  4. Yohei Chiba1,
  5. Sho Sato1,
  6. Eriko Takatori1,
  7. Yositaka Kaido1,
  8. Masahiro Kagabu1,
  9. Tsukasa Baba1 and
  10. Yoshihito Yokoyama2
  1. 1Iwate Medical University School of Medicine, Obstetrics and Gynecology, Yahaba, Iwate,, Japan
  2. 2Hirosaki University, Department of Obstetrics and Gynecology, Hirosaki, Japan


Introduction Recurrent cervical non-squamous cell carcinoma (non-SCC) is resistant to treatment and has a poor prognosis. The efficacy and safety of S-1/oxaliplatin (SOX) therapy in patients with recurrent non-SCC of uterine cervix were examined in a phase II study.

Methods Fourteen patients were enrolled from January 2013 to December 2022. S-1 was orally administered for 14 days at a dose of 80–120 mg/body/day with oxaliplatin being administered intravenously at a dose of 100 mg/m2 on day 1. Each treatment cycle was 21 days, and repeated until disease progression or serious adverse events occurred. The antitumor effect, adverse events, progression-free survival (PFS), and overall survival (OS) were investigated.

Results The median age of the patients was 54 (41–73) years. The PS was 0 in 10 and 1 in 4 patients. The median number of prior regimens was 2 (1–5). The histological type was usual type adenocarcinoma in 10 patients, endometrioid carcinoma, clear cell carcinoma, signet-ring cell carcinoma and unclassified in 1. The overall response rate was 35.7%, and the disease control rate was 64.2%. As for hematologic toxicities of grade 3 or more severe, leukopenia, neutropenia, anemia and thrombocytopenia occurred in 21.4%, 35.7%, 42.8 and 35.7%, respectively, as for non-hematologic toxicities, fatigue occurred in 7.1%, of the patients. The median PFS and OS were 5 (1–17) months, 14 (3–23) months respectively.

Conclusion/Implications These results suggest that SOX therapy is useful for the treatment of recurrent non-SCC of uterine cervix, having a promising antitumor effect and minimal adverse effects.

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