Multicenter Phase II Trial Of Paclitaxel (P), Ifosfamide (I), And Carboplatin (C) In Previously Untreated Extensive Stage Small Cell Lung Cancer (ES?SCLC)

Reviewer: Roberto Santiago, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: May 19, 2002

Presenter: Marcus A Neubauer
Presenter's Affiliation: US Oncology Inc, Houston, TX
Type of Session: Poster

Background

ES-SCLC accounts for 60-70% of the 30-35,000 new cases of SCLC diagnosed each year in the US
The median survival for ES-SCLC reported in phase III trials is 9-12 months
Overall survival at 2 years is < 10% and little progress in survival outcomes has been made over the last decade
Platinum + etoposide are considered the standard of care but P, I, and C have been shown to be active as single agents as well as when parts of combination regimens.
A recent phase III trial showed improved survival in ES-SCLC patients treated with cisplatin and irinotecan
This phase II trial evaluates the activity and toxicity profile of a combination of P (175mg/m2/h), I (2.5 gm/m2/h with mesna), and C (AUC=6 over 0.5h) all given on day 1 and repeated every 21 days for 6 cycles
The regimen used was previously evaluated in patients with ES-SCLC refractory to platinum + etoposide (RR, 73%; median survival, 28 weeks; 1-year OS, 12%)

Materials and Methods

22 men and 13 women with clinically assessable, histologically confirmed ES-SCLC were enrolled
No previous chemotherapy was allowed; last radiotherapy a least 2 weeks prior to this regimen
Patients had an ECOG performing status between 0 and 2 (0-1, 86%) and a median age of 59 years (range 40?79)
Patients with previous malignancy, serious co-morbidities, or end-organ dysfunction were not eligible
A median of 6 cycles (range 1?6) were delivered per patient for a total of 193 cycles

Results

Grade 3 toxicity was observed in the following percent of patients: Neutropenia, 14%; anemia, 17%; platelets, 17%; neuropathy, 3%; nausea, 0%; CNS, 3%; HSR, 0%
Grade 4 toxicity was observed in the following percent of patients: Neutropenia, 66%; anemia, 0%; platelets, 3%; neuropathy, 0%; nausea, 0%; CNS, 0%; HSR, 3%
Grade 2 alopecia and myalgia/arthralgia were observed in 46% and 14% of the patients, respectively
Neutropenic fever was developed by 9% of the patients
1 treatment-related death occurred in a patient that had febrile neutropenia
The overall, complete, and partial response rates were 69%, 14% and 55%, respectively (23% are not assessable as of yet)
Median survival was 9.5 months, 1-year survival was 42% and 2-year survival was 12%

Author's Conclusions

PIC is an active and well tolerated regimen in ES-SCLC
Response rates and overall survival are similar to other regimens commonly used in ES-SCLC

Clinical/Scientific Implications

Neutropenia was the principal toxicity of this regimen
The regimen proved convenient for outpatient delivery since it was feasible to administer in a single half-day

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.