title: A randomized controlled trial comparing four versus six courses of adjuvant platinum-based chemotherapy in locally advanced cervical cancer patients previously treated with neo-adjuvant chemotherapy plus radical surgery.
abstract: OBJECTIVES. The aim of this study was to compare 4 versus 6 courses of adjuvant chemotherapy after neoadjuvant chemotherapy plus radical surgery in terms of overall survival (OS), disease-free survival (DFS), recurrence rate and toxicity profile. METHODS. We randomly assigned 200 patients with IB2-IIB cervical cancer to receive 4 (Group A) or 6 (Group B) courses of cisplatin 100 mg/mq and paclitaxel 175 mg/mq every 21 days. RESULTS. At 4-years follow-up, the comparison of recurrence rate (p = 1; RR = 1.005; 95% CI = 0.87 to 1.161), OS (p = 0.906) and DFS (p = 0.825) did not show statistically significant differences between the two groups. Data analysis showed statistically significant differences between the two groups in term of episodes of leukopenia (p = 0.0072; RR = 1.513; 95% CI = 1.127-2.03), anemia (p = 0.048; RR = 1.188; CI = 1.012-1.395) and febrile neutropenia (p = 0.042; RR = 1.119; 95% CI = 1.014-1.235), in favor of Group A. As regards non-hematological toxicities, there were no statistically significant differences in terms of gastrointestinal symptoms (p = 0.49; RR = 1.046; CI = 0.948-1.153. On the contrary, there was a statistically significant difference regarding neurological symptoms (p=0.014; RR=1.208; CI=1.046-1.395), that were less frequent in Group A (13%) than in Group B (28%). CONCLUSIONS. Adjuvant treatment with 4 or 6 courses of platinum-based chemotherapy showed similar results in terms of OS and DSF, with a favorable toxicity profile in favor of the first regimen.
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Angioli
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Plotti
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University, Rome, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Aloisi
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University, Rome, Italy. Electronic address: g.scaletta@unicampus.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Scaletta
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University, Rome, Italy.
authors.forename: Stella
authors.initials: S
authors.lastname: Capriglione
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University, Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Luvero
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University, Rome, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Fiore
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University, Rome, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Terranova
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Montera
authors.affiliation: Department of Obstetrics and Gynaecology, "La Sapienza" University of Rome, Italy.
authors.forename: Pierluigi Benedetti
authors.initials: PB
authors.lastname: Panici
mesh_terms: D000230:Adenocarcinoma / Q000556:secondary / Q000628:therapy*; D000328:Adult; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D018196:Carcinoma, Adenosquamous / Q000556:secondary / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000556:secondary / Q000628:therapy*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000209:etiology; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local / Q000000981:diagnostic imaging; D017239:Paclitaxel / Q000008:administration & dosage; D011859:Radiography; D011877:Radionuclide Imaging; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D017239:Paclitaxel; D002945:Cisplatin
keywords: Adjuvant chemotherapy; Cervical cancer; Randomized controlled trial