title: The role of docetaxel (Taxotere) as a single agent or in combination before local treatment of non-small cell lung cancer.
abstract: Neoadjuvant therapy in the treatment of stage IIIa/b non-small cell lung cancer (NSCLC) has the potential to reduce tumor size in patients whose tumors were previously inoperable. This report describes the design and status of an ongoing randomized, phase III study of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) as neoadjuvant treatment in patients with stage IIIa/b NSCLC, as well as of two phase II studies of combination neoadjuvant therapies. A phase III, multicenter, international, randomized trial is in progress which compares docetaxel with no neoadjuvant chemotherapy in patients with histologically confirmed, previously untreated NSCLC with stage IIIa N2(T0-3) or T3 (N0-1) disease or stage IIIb disease that can be treated radically. Patients are assigned to receive three cycles of docetaxel or no neoadjuvant therapy. Definitive therapy is administered immediately or within 6 weeks of the third cycle of docetaxel. The primary objective of the study is median survival. Secondary end points include response rate, tumor resectability, survival after surgery and after curative-intent radiation, time to disease progression, and quality of life. To date, 110 of the planned 292 patients have been randomized. It is anticipated that the study will be completed in 1998. A phase I/II dose escalation study of the combination of docetaxel and cisplatin as neoadjuvant treatment of patients with stage IIIa T1-T3 NSCLC with N2 disease on mediastinoscopy is ongoing. The objectives of the study are to determine the clinical response to chemotherapy, the pathologic response after surgery, and survival. A phase II, multicenter, nonrandomized trial of the combination of docetaxel and carboplatin as neoadjuvant therapy in patients with stage IIIa N2 NSCLC is in progress. The primary objective of the study is to determine the response rate after chemotherapy. The results of both studies should be available by late 1997. The ultimate hope is that there is potential for neoadjuvant chemotherapy to provide a significant benefit for patients with advanced NSCLC.
authors.affiliation: Department of Oncology, Guys Hospital, London, UK.
authors.forename: P
authors.initials: P
authors.lastname: Harper
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000628:therapy; D002945:Cisplatin / Q000008:administration & dosage; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D000077143:Docetaxel; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000628:therapy; D017239:Paclitaxel / Q000031:analogs & derivatives* / Q000627:therapeutic use; D043823:Taxoids
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin