Phase II randomized trial comparing vinorelbine versus vinorelbine plus cisplatin in patients with recurrent salivary gland malignancies

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Abstract
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/m2, on Day 1 plus VNB, 25 mg/m2, on Days 1 and 8 (every 3 weeks) (for a minimum of 3 cycles (Arm A [16 patients]), or VNB, 30 mg/m2/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. Cancer 2001;91:541–7. © 2001 American Cancer Society.