PT - JOURNAL ARTICLE AU - DE FELICE, FRANCESCA AU - FALLARINO, ALESSIA AU - IAFRATE, FRANCO AU - MAIURI, VERONICA AU - GALLONI, GIOVANNI AU - COLONNA, GIOVANNI TURRIZIANI AU - DE PIETRO, RAFFAELLA AU - CHIARELLO, GIUSEPPINA AU - MARCHETTI, CLAUDIA AU - BULZONETTI, NADIA AU - MUSIO, DANIELA AU - TOMBOLINI, VINCENZO TI - The INCH Trial – Induction Chemotherapy in Patients With Bulky Anal Canal Cancer: Evaluation of the Pilot Phase AID - 10.21873/anticanres.15105 DP - 2021 Jun 01 TA - Anticancer Research PG - 3187--3191 VI - 41 IP - 6 4099 - http://ar.iiarjournals.org/content/41/6/3187.short 4100 - http://ar.iiarjournals.org/content/41/6/3187.full SO - Anticancer Res2021 Jun 01; 41 AB - Aim: To assess feasibility, complications and efficacy of induction chemotherapy followed by standard chemoradiotherapy in patients with bulky anal canal cancer. Patients and Methods: Patients with squamous cell carcinoma of the anal canal, staged bulky tumor with or without nodal involvement were prospectively enrolled. Before standard chemoradiotherapy, patients received induction chemotherapy with 3 cycles of 75 mg/m2 cisplatin and 750 mg/m2 5-fluorouracil. Patients were followed-up routinely until recurrence or death. Results: Seven patients with bulky anal canal cancer were evaluable for this pilot phase of the study. All patients had human papillomavirus-negative disease. Five completed the scheduled induction chemotherapy and all patients completed the programmed concomitant chemoradiotherapy. None had severe hematological toxicity. The majority of patients (6/7) had tumor downsizing after induction treatment. Six months after chemoradiotherapy, complete response was documented in three patients and salvage surgery was performed in two cases. With a median follow-up of 38 months (range=28-48 months), two patients are disease-free survivors. Conclusion: Induction chemotherapy has the potential to become a standard approach in patients with bulky human papillomavirus-negative anal canal cancer.