Abstract:
BACKGROUND:The necessity to develop more effective chemotherapy regimens in advanced nonsmall cell lung carcinoma (NSCLC) prompted the authors to evaluate the paclitaxel-ifosfamide-cisplatin (PIC) combination, developed on the basis of high individual single-agent activity, in vitro synergism, and tolerance as determined in a previous Phase I study by the authors. PATIENTS:Eligibility criteria included advanced NSCLC (American Joint Committee on Cancer [AJCC]/International Union Against Cancer [UICC] Stage III/IV), Eastern Cooperative Oncology Group performance status (PS) = 2, no prior chemotherapy, and unimpaired hematopoietic and organ function. Chemotherapy included, paclitaxel 175 (in the first 10 patients) or 200 mg/m(2) on Day 1, ifosfamide: 5 g/m(2) divided over Days 1 and 2, and cisplatin 100 mg/m(2) divided over Days 1 and 2, recycled every 21 days. Granulocyte-colony stimulating factor was administered from Day 4 to 13 or until leukocyte count reached >/= 10,000/microL. RESULTS:Fifty patients were entered, and all were evaluable for response and toxicity: median age, 58 years (range, 40-72), PS, 1 (range, 0-2), Gender: 44 males and 6 females, Stages IIIA, 6 patients; IIIB, 17; IV, 27; histologies: adenocarcinoma, 27 patients; squamous, 17; large cells, 5; unspecified, 1. Metastatic sites at diagnosis included lymph nodes, 33 patients; bone, 6; liver, 5; brain, 10; lung nodules, 7; adrenals, 6; other, 2. Thirty-two of 50 (64%; confidence interval, 50.7-77.3%) evaluable patients responded: 4 complete remissions, 28 partial remissions, 13 stable disease, and 5 progressive disease. The quality-of-life score improved in 37 of 50 (74%) patients. The median response duration was 7 months (range 2-34+); median time-to-progression, 8 months (range, 1-36+), median overall survival, 12 months (range, 2-36+). One-year survival was 53%. Grade 3 and 4 toxicities included neutropenia 38 of 50 patients with 21 developing Grade 4 neutropenia (= 5 days) and 7 of these febrile neutropenia (14%); thrombocytopenia, 4 of 50 patients with 1 Grade 4 requiring platelet transfusions, 1 Grade 3 neuropathy; Grade 1-2 central nervous system toxicity due to ifosfamide was seen in 22 patients, no renal toxicity, 15 Grade 2 myalgias, 17 Grade 2 diarrhea, and 10 Grade 3 vomiting. CONCLUSIONS:The PIC combination appears highly active and tolerable in advanced NSCLC administered in the outpatient setting. Future randomized comparisons to other current standard regimens in NSCLC will be warranted.
journal_name
Cancerjournal_title
Cancerauthors
Kosmas C,Tsavaris NB,Polyzos A,Kalofonos HP,Sepsas E,Malamos NA,Vadiaka M,Dosios T,Antonopoulos MJdoi
10.1002/1097-0142(20000815)89:4<774::aid-cncr9>3.0subject
Has Abstractpub_date
2000-08-15 00:00:00pages
774-82issue
4eissn
0008-543Xissn
1097-0142pii
10.1002/1097-0142(20000815)89:4<774::AID-CNCR9>3.0journal_volume
89pub_type
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