Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine: the TREAT study.

BACKGROUND: Adjuvant chemotherapy is beneficial in non-small-cell lung cancer (NSCLC). However, balancing toxicity and efficacy mandates improvement. PATIENTS AND METHODS: Patients with completely resected stages IB-pT3N1 NSCLC were randomly assigned to either four cycles cisplatin (C: 50 mg/m(2) day (d)1 + 8) and vinorelbine (V: 25 mg/m(2) d1, 8, 15, 22) q4 weeks or four cycles cisplatin (75 mg/m(2) d1) and pemetrexed (Px: 500 mg/m(2) d1) q3 weeks. Primary objective was the clinical feasibility rate (no grade (G)4 neutropenia/thrombocytopenia or thrombocytopenia with bleeding, no G3/4 febrile neutropenia or non-hematological toxicity; no premature withdrawal/death). Secondary objectives were drug delivery and efficacy. RESULTS: One hundred and thirty two patients were randomized (stages: 38% IB, 10% IIA, 47% IIB, 5% pT3pN1; histology: 43% squamous, 57% non-squamous). The feasibility rates were 95.5% (cisplatin and pemetrexed, CPx) and 75.4% (cisplatin and vinorelbine, CVb) (P = 0.001); hematological G3/4 toxic effects were 10% (CPx) and 74% (CVb) (P < 0.001), non-hematological toxic effects were comparable (33% and 31%, P = 0.798). Delivery of total mean doses was 90% of planned with CPx, but 66% (cisplatin) and 64% (vinorelbine) with CVb (P < 0.0001). The median number of cycles [treatment time (weeks)] was 4 for CPx (11.2) and 3 for CVb (9.9). Time to withdrawal from therapy differed significantly between arms favoring CPx (P < 0.001). CONCLUSION: Adjuvant chemotherapy with CPx is safe and feasible with less toxicity and superior dose delivery compared with CVb.

Management of chylothorax in adults: when is surgery indicated?

BACKGROUND: The aim of this retrospective study was to analyze the etiology, management and outcome of patients with chylothorax and identify clinical parameters for appropriate treatment decisions. METHODS: We analyzed 82 cases of chylothorax in 75 patients. In 37 cases (45 %) the cause of chylothorax was surgery, in 45 cases (55 %), the etiology was nonsurgical (malignancy n = 17 [21 %], lymphatic disorders n = 5 [6 %], hepatic cirrhosis, n = 4 [5 %], trauma n = 1 and other causes n = 18 [22 %]). RESULTS: Conservative treatment was successful in 13 (16 %) cases. In 25 cases (total 31 %, postsurgical n = 19 [51 %], nonsurgical n = 6 [13 %]) a (redo) thoracotomy with ligation of the thoracic duct or repeat surgical procedure was performed. The quantity of chyle drained per 24 hours appeared to be the best indicator to guide management decisions. CONCLUSION: Chylothoraces that occur postoperatively following thoracic procedures require redo operations in approximately 50 % of cases, whereas nonsurgical causes rarely require surgical intervention. In postoperative chylothoraces with a high flow leak > 900 mL/24 h revision should be performed early on, since conservative management is likely to be unsuccessful.

Pulmonary metastasectomy following chemotherapy in patients with testicular tumors: experience in 52 patients.

BACKGROUND: Surgical resection is an important form of treatment for residual post-chemotherapy pulmonary masses in patients with non-seminomatous germ cell tumors. We analyzed the outcome and prognostic factors after surgery. METHODS: Between 1996 and 2001, 52 patients underwent pulmonary resection of thoracic masses following cisplatin-based chemotherapy. These patients' records were subsequently reviewed. RESULTS: The overall 5-year survival rate was 75.8 %. A significantly longer survival was observed using multivariate analysis in patients with normal serum AFP and/or hCG tumor marker levels and after complete surgical resection. In patients with viable malignant tumor cells in the resected specimen and in patients with only necrosis/fibrosis or teratoma, the 5-year survival rates were 49.6 % and 82.8 %, respectively. This difference was only statistically significant in univariate analysis. CONCLUSIONS: We conclude that pulmonary resection in metastatic non-seminomatous germ cell tumors is a safe and effective treatment modality. Incomplete resection and elevated tumor marker levels, AFP and/or hCG, were identified as prognosis-related criteria for a poor outcome in multivariate analysis.