title: Phase II study of neoadjuvant chemotherapy with irinotecan hydrochloride             and nedaplatin followed by radical hysterectomy for bulky stage Ib2 to IIb, cervical             squamous cell carcinoma: Japanese Gynecologic Oncology Group study (JGOG 1065).
abstract: The efficacy and adverse events of neoadjuvant chemotherapy with irinotecan             hydrochloride and nedaplatin were evaluated in patients with bulky stage Ib2 to             IIb cervical squamous cell carcinoma. Eligibility included patients who received             irinotecan (60 mg/m2) on days 1 and 8 and nedaplatin (80 mg/m2) on day 1 of a             21-day cycle. After 1-3 courses of chemotherapy, radical hysterectomy was performed.             Sixty-eight patients were enrolled. Sixty-six were included in the full analysis             set. Their median age was 47 years (range 22-71), the FIGO stage was Ib2 in 18             patients, IIa in 10, and IIb in 38. Radical hysterectomy was performed after NAC             in 63 patients (95.5%). The number of administered courses of NAC was 1 in 13             patients, 2 in 43, and 3 in 10. The response rate, the primary endpoint of this             study, was 75.8% (CR in 2 patients, PR in 48, SD in 12, PD in 0, and NE in 4).             The mean number of treatment courses required for a response was 1.42 (1 course             in 30 patients, 2 courses in 19, and 3 courses in 1). The incidences of grade             3 or 4 hematological toxicities were: neutropenia 72.2%, leukopenia 16.7%, anemia             13.6%, thrombocytopenia 7.6%, febrile neutropenia 1.5%, and elevations of alanine             aminotransferase and aspartate aminotransferase 1.5%. Grade 3 or 4 non-hematologic             toxicities were as follows: diarrhea 6.1%, nausea 3%, anorexia 1.5%, vomiting             1.5%, fever 1.5%, allergic reactions 1.5%, ileus 1.5% and vesicovaginal fistula             1.5%. Neoadjuvant chemotherapy with irinotecan and nedaplatin was an effective             and well-tolerated treatment for patients with bulky stage Ib2 to IIb squamous             cell carcinoma of the uterine cervix.
authors.affiliation: Department of Gynecologic Oncology, Hyogo Cancer Center, Akashi, Hyogo 673-8558, Japan. s-yama@hp.pref.hyogp.jp
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yamaguchi
authors.forename: Ryuichiro
authors.initials: R
authors.lastname: Nishimura
authors.forename: Nobuo
authors.initials: N
authors.lastname: Yaegashi
authors.forename: Kazushige
authors.initials: K
authors.lastname: Kiguchi
authors.forename: Toru
authors.initials: T
authors.lastname: Sugiyama
authors.forename: Tsunekazu
authors.initials: T
authors.lastname: Kita
authors.forename: Kaneyuki
authors.initials: K
authors.lastname: Kubushiro
authors.forename: Katsuji
authors.initials: K
authors.lastname: Kokawa
authors.forename: Masamichi
authors.initials: M
authors.lastname: Hiura
authors.forename: Katsumi
authors.initials: K
authors.lastname: Mizutani
authors.forename: Kaichiro
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Ken
authors.initials: K
authors.lastname: Takizawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000379:methods; D000077146:Irinotecan; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D055815:Young Adult
chemical_list: D009944:Organoplatinum Compounds; D000077146:Irinotecan; C053989:nedaplatin; D002166:Camptothecin