We conducted a phase I/II study to investigate whether the surgical resection after induction chemotherapy with cisplatin and irinotecan was feasible and could improve the treatment outcome for patients with pathological N 2 non-small cell lung cancer. Fifteen patients with stage IIIA non-small cell lung cancer having mediastinal lymph node metastases proved by mediastinoscopy were eligible. Both cisplatin (60 mg m 72 ) and irinotecan (50 mg m 72 ) were given on days 1 and 8. Patients received two cycles of chemotherapy after 3 -4 weeks interval. Induction was followed by surgical resection in 4 -6 weeks. Patients who had documented tumour regression after preoperative chemotherapy received two additional cycles of chemotherapy and other patients received radiotherapy postoperatively. After the induction chemotherapy, the objective response rate was 73%. All the 15 patients received surgical resection and complete resection was achieved in 11 (73%) patients. There was no operation-related death and one death due to radiation pneumonitis during postoperative radiotherapy. The median time from entry to final analysis was 46.5 months, ranging from 22 to 68 months. The 5-year survival rate was 40% for all the 15 patients and it was 55% for the 11 patients who underwent complete resection. We conclude that the surgical resection after induction chemotherapy with cisplatin and irinotecan is feasible, and associated with low morbidity and high respectability. The prognosis for non-small-cell lung cancer (NSCLC) with metastases in mediastinal nodes after surgery is generally poor because distant micrometastases are frequently present. If these nodes are found before operation by mediastinoscopy and treated with surgical resection and postoperative irradiation, the 5-year survival is only approximately 10% (Pearson et al, 1982). Although many studies have been performed to evaluate adjuvant chemotherapy, the results of these studies have been disappointing on the whole. Recently, several neoadjuvant treatment schedules using induction chemotherapy (Roth et al, 1998;Rosell et al, 1999) or chemoradiotherapy (Rusch et al, 1993;Albain et al, 1995; Sugarbaker et al, 1995;Mathisen et al, 1996; Rice et al, 1998) followed by surgical resection have shown encouraging results.We have recently reported the results of combination chemotherapy of cisplatin (CDDP) and irinotecan (CPT-11) for unresectable NSCLC (Ueoka et al, 1999). The objective response rate was 76% and the toxicity was manageable. The purpose of this study was to assess toxicity, response, and survival in patients with pathological N2, stage IIIA NSCLC who received induction chemotherapy with CDDP and CPT-11.
MATERIALS AND METHODS
Patient selectionInitial staging evaluation included complete history and physical examination, a complete blood cell count, standard chemistry profile, urinalysis, 24-h urine creatinine clearance, electrocardiogram, bronchoscopy, arterial blood gas analysis and pulmonary function test. Pretreatment chest X-ray, bone scan and CT of brain, ...