S. Gordeev, A. A. Naguslaeva, M. Chernykh, E. Rybakov, V. Ivanov, A. Zagidullina, A. Seydinovich, Z. Mamedli
{"title":"在肛门鳞状细胞癌的放化疗中加入紫杉醇:一项前瞻性随机3期试验","authors":"S. Gordeev, A. A. Naguslaeva, M. Chernykh, E. Rybakov, V. Ivanov, A. Zagidullina, A. Seydinovich, Z. Mamedli","doi":"10.33878/2073-7556-2022-21-4-30-38","DOIUrl":null,"url":null,"abstract":"AIM: to compare long-term outcomes and safety of the addition of paclitaxel to chemoradiotherapy for squamous cell anal carcinoma.PATIENTS AND METHODS: A prospective phase 3 randomized trial included patients with histologically verified non-metastatic anal squamous cell carcinoma. Patients received radiotherapy 52-54 Gy (for T1-T2 tumors) and 56-58 Gy (for T3- T4 tumors) in 2 Gy daily fractions during chemotherapy with mitomycin C (10 mg/m2 i.v. day 1), capecitabine (625 mg/m2 2 times a day orally on days of radiation therapy), paclitaxel (45 mg/m2 i.v. on days 3, 10 , 17, 24, 31) during 2013-2019. In the control group patients received a similar course of RT and chemotherapy with mitomycin C (12 mg/m2 i.v. day 1 ), capecitabine (825 mg/m2 2 times a day orally on radiotherapy days). The primary endpoint was 3-year disease-free survival (DFS). Secondary endpoints included complication rate (NCI-CTCAE 4.0), complete clinical response rate at 12 weeks and 26 weeks after completion of CRT, and 3-year overall survival (OS).RESULTS: The study and control groups included 72 patients each. The median follow-up was 39.5 months. A complete clinical response at the 26-week follow-up was recorded in 64 (88.9%) patients in the study group and in 54 (75%) patients in the control group (p=0.049). There were no differences in the incidence of complications of grades 3-4 in the two groups (39/72 [54.2%] in the study group versus 35/72 [48.6%] in the control group (p=0.617)). Three-year progression-free survival in the study group was 87.1%, in the control group - 64.4% (p=0.001). Three-year overall survival in the study group was 95.5%, in the control group - 80.0% (p<0.001).CONCLUSION: CRT with paclitaxel for squamous cell anal carcinoma has acceptable toxicity and may improve long-term treatment outcomes.","PeriodicalId":17840,"journal":{"name":"Koloproktologia","volume":"48 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The addition of paclitaxel in chemoradiotherapy of anal squamous cell carcinoma: a prospective randomized phase 3 trial\",\"authors\":\"S. Gordeev, A. A. Naguslaeva, M. Chernykh, E. Rybakov, V. Ivanov, A. Zagidullina, A. Seydinovich, Z. Mamedli\",\"doi\":\"10.33878/2073-7556-2022-21-4-30-38\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"AIM: to compare long-term outcomes and safety of the addition of paclitaxel to chemoradiotherapy for squamous cell anal carcinoma.PATIENTS AND METHODS: A prospective phase 3 randomized trial included patients with histologically verified non-metastatic anal squamous cell carcinoma. Patients received radiotherapy 52-54 Gy (for T1-T2 tumors) and 56-58 Gy (for T3- T4 tumors) in 2 Gy daily fractions during chemotherapy with mitomycin C (10 mg/m2 i.v. day 1), capecitabine (625 mg/m2 2 times a day orally on days of radiation therapy), paclitaxel (45 mg/m2 i.v. on days 3, 10 , 17, 24, 31) during 2013-2019. In the control group patients received a similar course of RT and chemotherapy with mitomycin C (12 mg/m2 i.v. day 1 ), capecitabine (825 mg/m2 2 times a day orally on radiotherapy days). The primary endpoint was 3-year disease-free survival (DFS). Secondary endpoints included complication rate (NCI-CTCAE 4.0), complete clinical response rate at 12 weeks and 26 weeks after completion of CRT, and 3-year overall survival (OS).RESULTS: The study and control groups included 72 patients each. The median follow-up was 39.5 months. A complete clinical response at the 26-week follow-up was recorded in 64 (88.9%) patients in the study group and in 54 (75%) patients in the control group (p=0.049). There were no differences in the incidence of complications of grades 3-4 in the two groups (39/72 [54.2%] in the study group versus 35/72 [48.6%] in the control group (p=0.617)). Three-year progression-free survival in the study group was 87.1%, in the control group - 64.4% (p=0.001). Three-year overall survival in the study group was 95.5%, in the control group - 80.0% (p<0.001).CONCLUSION: CRT with paclitaxel for squamous cell anal carcinoma has acceptable toxicity and may improve long-term treatment outcomes.\",\"PeriodicalId\":17840,\"journal\":{\"name\":\"Koloproktologia\",\"volume\":\"48 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-12-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Koloproktologia\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.33878/2073-7556-2022-21-4-30-38\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Koloproktologia","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.33878/2073-7556-2022-21-4-30-38","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
The addition of paclitaxel in chemoradiotherapy of anal squamous cell carcinoma: a prospective randomized phase 3 trial
AIM: to compare long-term outcomes and safety of the addition of paclitaxel to chemoradiotherapy for squamous cell anal carcinoma.PATIENTS AND METHODS: A prospective phase 3 randomized trial included patients with histologically verified non-metastatic anal squamous cell carcinoma. Patients received radiotherapy 52-54 Gy (for T1-T2 tumors) and 56-58 Gy (for T3- T4 tumors) in 2 Gy daily fractions during chemotherapy with mitomycin C (10 mg/m2 i.v. day 1), capecitabine (625 mg/m2 2 times a day orally on days of radiation therapy), paclitaxel (45 mg/m2 i.v. on days 3, 10 , 17, 24, 31) during 2013-2019. In the control group patients received a similar course of RT and chemotherapy with mitomycin C (12 mg/m2 i.v. day 1 ), capecitabine (825 mg/m2 2 times a day orally on radiotherapy days). The primary endpoint was 3-year disease-free survival (DFS). Secondary endpoints included complication rate (NCI-CTCAE 4.0), complete clinical response rate at 12 weeks and 26 weeks after completion of CRT, and 3-year overall survival (OS).RESULTS: The study and control groups included 72 patients each. The median follow-up was 39.5 months. A complete clinical response at the 26-week follow-up was recorded in 64 (88.9%) patients in the study group and in 54 (75%) patients in the control group (p=0.049). There were no differences in the incidence of complications of grades 3-4 in the two groups (39/72 [54.2%] in the study group versus 35/72 [48.6%] in the control group (p=0.617)). Three-year progression-free survival in the study group was 87.1%, in the control group - 64.4% (p=0.001). Three-year overall survival in the study group was 95.5%, in the control group - 80.0% (p<0.001).CONCLUSION: CRT with paclitaxel for squamous cell anal carcinoma has acceptable toxicity and may improve long-term treatment outcomes.