PROVIDENCE, RI--Weekly chemotherapy with carboplatin(Drug information on carboplatin) (Paraplatin) and paclitaxel(Drug information on paclitaxel) (Taxol) followed by irradiation resulted in a 91% overall response rate in patients with inoperable cancer of the head and neck.
The regimen led to 20 complete responses and 10 partial responses among 33 patients. Post-treatment biopsies confirmed the absence of residual disease in 17 of the 20 patients who had a complete response, Prakash Chougule, MD, of the Brown University Oncology Group, said at an ASCO poster session.
All patients had histologically documented grade 3-4 squamous cell carcinoma of the head and neck. No patient had received prior radiation therapy or chemotherapy. Involved sites included the larynx (9 patients), hypopharynx (7), oropharynx (8), oral cavity (6), and nasopharynx (3). Sixteen patients had positive lymph nodes.
Each patient received 8 weekly cycles of therapy with paclitaxel at a dose of 60 mg/m² and carbo-platin dosed to an AUC of 1, with concurrent fractionated external-beam radiation at a total tumor dose of 6,660 cGy to 7,200 cGy.
At a median follow-up of about a year and a half, only three patients had not responded to the therapy. On the basis of post-therapy biopsies, 61% of patients had achieved a complete remission, and an additional 30% had a partial response. Eight patients with clinically positive lymph nodes had nodal biopsies, and five had pathologically negative findings.
Mucositis was the major toxicity, as all but three patients developed grade 3-4 mucosal irritation. Seven patients each had grade 3 skin toxicity and candidal infections. Three patients became dehydrated, and two experienced neuromotor effects.
The results suggest that the therapy might extend the possibility of organ preservation to more patients, Dr. Chougule and his colleagues concluded, but longer follow-up is necessary to determine whether the therapy confers a survival advantage.