Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass

• Published in: International journal of clinical oncology Vol. 21; no. 6; pp. 1120 - 1127
• Main Authors: Shoji, Tadahiro, Takatori, Eriko, Furutake, Yoko, Takada, Anna, Nagasawa, Takayuki, Omi, Hideo, Kagabu, Masahiro, Honda, Tatsuya, Miura, Fumiharu, Takeuchi, Satoshi, Kumagai, Seisuke, Yoshizaki, Akira, Sato, Akira, Sugiyama, Toru
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01.12.2016; Springer Nature B.V
• Subjects: Adult; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Cancer Research; Cancer therapies; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - therapy; Cervical cancer; Chemotherapy; Cisplatin - administration & dosage; Cisplatin - adverse effects; Disease-Free Survival; Dose-Response Relationship, Drug; Female; Humans; Hysterectomy - methods; Lymphatic Metastasis; Medicine; Medicine & Public Health; Middle Aged; Neoadjuvant Therapy - methods; Neoplasm Staging; Neutropenia - diagnosis; Neutropenia - etiology; Oncology; Original; Original Article; Prognosis; Surgical Oncology; Survival Rate; Treatment Outcome; Uterine Cervical Neoplasms - pathology; Uterine Cervical Neoplasms - therapy; NAC; Bulky mass; CDDP; CPT-11; Cervical cancer
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-016-1008-7

Background We examined the efficacy and safety of neoadjuvant chemotherapy (NAC) with the CPT-11 + CDDP regimen in combination with radical hysterectomy. Subjects and methods The subjects were 42 patients with stages IB2 to IIIB squamous cell carcinoma of the uterine cervix with a bulky mass. CDDP at 70 mg/m 2 was intravenously administered on day 1 and CPT-11 at 70 mg/m 2 was intravenously administered on days 1 and 8 of a 21-day cycle. In principle, two cycles were administered followed by radical hysterectomy. We examined antitumor efficacy, adverse events, completion rate of radical hysterectomy, operative time, surgical blood loss, progression-free survival (PFS), and overall survival (OS). Results The antitumor effect was complete response in 7 patients, partial response in 28, stable disease in 6, and progressive disease in 1; the response rate was 83.3 % (95 % confidence interval, 68.6–93.0). Grade 3 or more severe neutropenia, anemia, and platelet count decreases were noted in 23 (54.8 %), 4 (9.5 %), and 1 (2.4 %) patient, respectively. Grade 3 nausea occurred in 3 patients (7.1 %), vomiting in 1 (2.4 %), and grade 3 febrile neutropenia in 2 (7.1 %). The completion rate of radical hysterectomy was 88.1 %. The median operative time and surgical blood loss were 260 min (range, 210–334) and 500 ml (range, 393–898), respectively. The 5-year PFS rate was 67.2 %, and the 5-year OS rate was 68.0 %. In multivariate analysis, lymph node metastasis before NAC [hazard ratio (HR), 34.88] and non-response to NAC (HR 30.58) were significant prognostic factors. Conclusion NAC with the CDDP/CPT-11 regimen achieves a high antitumor efficacy with moderate adverse reactions, allowing safe radical hysterectomy, and is thus considered to be a useful therapeutic method that can improve prognosis.