title: Phase II trial of paclitaxel, ifosfamide, and carboplatin in extensive-stage small cell lung cancer.
abstract: Extensive-stage small cell lung cancer (ES-SCLC) remains a therapeutic challenge to the medical oncologists. We evaluated the triplet combination of paclitaxel (175 mg/m(2) over 1 h), ifosfamide (2.5 gm/m(2) over 1 h) and carboplatin (AUC=6 over 0.5 h) (PIC) all given on day 1 of a 21 day schedule. Thirty-five patients were entered with a median age of 59 years (range 40-79). The ECOG PS was 0-1 in 86%. A median of 6 cycles were delivered (range 1-6). The principal toxicity was neutropenia with 66% of patients experiencing grade 4 neutropenia. Only 9% of patients experienced febrile neutropenia. One treatment-related death (3%) due to neutropenic sepsis occurred. Non-hematologic toxicity was minimal. The overall response rate was 71% (15% complete response, 56% partial responses). Quality of life appeared to be stable across time. The median survival time was 9.5 months (95% confidence interval (CI), 6.7-13.2 months) with a 1- and 2-year survival rates of 43% (95% CI, 26-59%) and 16% (95% CI, 2-30%). PIC has activity in ES-SCLC and is associated with a response rate and survival profile similar to other combinations in this disease setting. This regimen has a tolerable toxicity profile and a favorable and convenient administration schedule.
authors.affiliation: Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, and US Oncology, Houston, TX, USA. socinski@med.unc.edu
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
authors.forename: Marcus A
authors.initials: MA
authors.lastname: Neubauer
authors.forename: Jairo
authors.initials: J
authors.lastname: Olivares
authors.forename: Steven
authors.initials: S
authors.lastname: Ketchel
authors.forename: Maureen
authors.initials: M
authors.lastname: Tynan
authors.forename: Martha
authors.initials: M
authors.lastname: Moore
authors.forename: Ji-Hyun
authors.initials: JH
authors.lastname: Lee
authors.forename: Kim
authors.initials: K
authors.lastname: Davis
authors.forename: Michael
authors.initials: M
authors.lastname: Schell
authors.forename: David
authors.initials: D
authors.lastname: Garfield
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000009:adverse effects / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D015996:Survival Rate; D043823:Taxoids
chemical_list: D043823:Taxoids; D017239:Paclitaxel; D002945:Cisplatin; D007069:Ifosfamide