BACKGROUND: Some previous studies have shown that vinorelbine (VNB) is active in recurrent salivary gland tumors. METHODS:Between April 1993 and April 1997, 36 patients in a Phase II randomized trial received either cisplatin, 80 mg/m(2), on Day 1 plus VNB, 25 mg/m(2), on Days 1 and 8 (every 3 weeks) (for a minimum of 3 cycles (Arm A [16 patients]), or VNB, 30 mg/m(2)/week, (for a minimum of 9 wks) (Arm B [20 patients]). There were 23 males and 13 females with a median age of 59 years (range, 20-74 years) and a median Eastern Cooperative Oncology Group performance status of 1 (range, 0-2). Four patients had been treated with prior surgery (S) orradiotherapy (RT), 27 patients had been treated with S plus RT, and 5 patients had been treated with S plus RT plus mitoxantrone. Eighteen patients had major salivary gland tumors, and 18 patients had minor salivary gland tumors; 9 patients had adenocarcinoma, 22 patients had adenoid cystic carcinoma, 1 patient had a malignant mixed carcinoma, 3 patients had undifferentiated carcinoma, and 1 patient had a mucoepidermoid carcinoma. The site of recurrence was local in 16 patients, local plus metastatic in 5 patients, and metastatic only in 15 patients. These characteristics were well balanced between the 2 arms. RESULTS: In Arms A and B a complete response (CR) was noted in 3 patients (19%) and no patients, respectively; a partial response (PR) was noted in 4 patients (25%) and 4 patients (20%), respectively; no change was noted in 6 patients (37.5%) and 9 patients (45%), respectively; and progressive disease was noted in 3 patients (19%) and 7 patients (35%), respectively. The median duration of the CR was 15+ months (range, 6-27+ months) and for PR the median duration was 7.5 months (range, 3-11+ months) and 6 months (range, 3-9 months) in Arms A and B, respectively. Number of patients surviving > 12 months was 6 versus 1 in Arms A and B, respectively (P < 0.05). Grade 2-3 nausea and emesis was statistically higher (P < 0.001) in Arm A; there was no significant difference with regard to other side-effects between the two treatment arms. CONCLUSIONS:VNB is a drug with moderate activity in salivary gland malignancies. The combination of cisplatin plus VNB was found to be more active than VNB alone, with a good number of CRs and long-term survivors reported in the current study. Copyright 2001 American Cancer Society.
RCT Entities:
BACKGROUND: Some previous studies have shown that vinorelbine (VNB) is active in recurrent salivary gland tumors. METHODS: Between April 1993 and April 1997, 36 patients in a Phase II randomized trial received either cisplatin, 80 mg/m(2), on Day 1 plus VNB, 25 mg/m(2), on Days 1 and 8 (every 3 weeks) (for a minimum of 3 cycles (Arm A [16 patients]), or VNB, 30 mg/m(2)/week, (for a minimum of 9 wks) (Arm B [20 patients]). There were 23 males and 13 females with a median age of 59 years (range, 20-74 years) and a median Eastern Cooperative Oncology Group performance status of 1 (range, 0-2). Four patients had been treated with prior surgery (S) or radiotherapy (RT), 27 patients had been treated with S plus RT, and 5 patients had been treated with S plus RT plus mitoxantrone. Eighteen patients had major salivary gland tumors, and 18 patients had minor salivary gland tumors; 9 patients had adenocarcinoma, 22 patients had adenoid cystic carcinoma, 1 patient had a malignant mixed carcinoma, 3 patients had undifferentiated carcinoma, and 1 patient had a mucoepidermoid carcinoma. The site of recurrence was local in 16 patients, local plus metastatic in 5 patients, and metastatic only in 15 patients. These characteristics were well balanced between the 2 arms. RESULTS: In Arms A and B a complete response (CR) was noted in 3 patients (19%) and no patients, respectively; a partial response (PR) was noted in 4 patients (25%) and 4 patients (20%), respectively; no change was noted in 6 patients (37.5%) and 9 patients (45%), respectively; and progressive disease was noted in 3 patients (19%) and 7 patients (35%), respectively. The median duration of the CR was 15+ months (range, 6-27+ months) and for PR the median duration was 7.5 months (range, 3-11+ months) and 6 months (range, 3-9 months) in Arms A and B, respectively. Number of patients surviving > 12 months was 6 versus 1 in Arms A and B, respectively (P < 0.05). Grade 2-3 nausea and emesis was statistically higher (P < 0.001) in Arm A; there was no significant difference with regard to other side-effects between the two treatment arms. CONCLUSIONS:VNB is a drug with moderate activity in salivary gland malignancies. The combination of cisplatin plus VNB was found to be more active than VNB alone, with a good number of CRs and long-term survivors reported in the current study. Copyright 2001 American Cancer Society.
Authors: Yoshitsugu Mitani; Pulivarthi H Rao; Sankar N Maity; Yu-Chen Lee; Renata Ferrarotto; Julian C Post; Lisa Licitra; Scott M Lippman; Merrill S Kies; Randal S Weber; Carlos Caulin; Sue-Hwa Lin; Adel K El-Naggar Journal: Clin Cancer Res Date: 2014-10-14 Impact factor: 12.531
Authors: Prashanth J Prabakaran; Amal M Javaid; Adam D Swick; Lauryn R Werner; Kwangok P Nickel; Emmanuel Sampene; Rong Hu; Irene M Ong; Justine Y Bruce; Gregory K Hartig; Aaron M Wieland; Jude Canon; Paul M Harari; Randall J Kimple Journal: Clin Cancer Res Date: 2017-06-28 Impact factor: 12.531