CaroleHammett Posted June 20, 2008 Posted June 20, 2008 A rare finding showing a targeted therapy that actually has higher success rate for squamous cell carcinoma: http://www.asco.org/ASCO/Abstracts+%26+ ... ctID=33541 2008 ASCO Annual Meeting, Abstract No. 8015: High activity of the anti-IGF-IR antibody CP-751,871 in combination with paclitaxel and carboplatin in squamous NSCLC. (Sub-category: Metastatic Lung Cancer. Category: Lung Cancer--Metastatic Lung Cancer) Citation: J Clin Oncol 26: 2008 (May 20 suppl; abstr 8015) Author(s): D. D. Karp, L. G. Paz-Ares, S. Novello, P. Haluska, L. Garland, F. Cardenal, L. J. Blakely, P. D. Eisenberg, A. Gualberto, C. J. Langer Background: CP-751,871 is a fully human, IgG2 monoclonal antibody against the Insulin-like Growth Factor type I Receptor (IGF-IR). We reported (ASCO 2007) a preliminary 46% Objective Response Rate (ORR) for the combination of CP-751,871 (I) with Paclitaxel (T) and Carboplatin © in 73 patients (pts) with advanced treatment-naïve NSCLC and performance status 0-1 enrolled in a multi-center phase 2 non-comparative study of TCI and TC with a primary endpoint of ORR by RECIST. The statistical hypotheses were 28% (null) versus 40% (response of interest). Methods: An additional 108 pts have been enrolled. Pts were randomized (2:1) to T (200 mg/m2), C (AUC of 6) and I (10 or 20 mg/kg), or TC alone every 3 weeks for up to 6 cycles; pts receiving TCI with response (PR) or stable disease were eligible to continue I as single agent until disease progression following discontinuation of chemotherapy. Pts progressing on TC alone were eligible to receive I as single agent or in combination with TC at the judgment of the investigator. Results: Safety and efficacy information are available for 178 and 143 pts, respectively (70% male, 45% > 65 years old, 82% stage IV, 49% adenocarcinoma, 20% squamous cell carcinoma). Median number of treatment cycles was 4, with 24.6% of pts receiving single agent I beyond cycle 6. TCI was well tolerated. All causality grade 3,4 toxicity included (TCI, TC): hyperglycemia (11%, 4%), fatigue (9%, 7%), and neutropenia (14%, 14%). Forty-three of 85 pts receiving TCI (51%, p<0.001) and 21 of 58 pts (36%) on TC alone had objective responses. Of note, 13 of 18 TCI pts (72%, p<0.001) with squamous cell carcinoma responded to treatment, including 6 striking responses in pts with bulky disease, 2 pts with no further evidence of disease and a reversal of a superior vena cava obstruction. Five of 12 squamous pts (42%) responded to TC alone. Clinical benefit (PR/SD) was also observed in 3 squamous TC pts receiving I upon progression on TC alone. At present, only 38% of pts on study have progressed. Hazard ratio for progression free survival is 1.18 in favor of TCI. Conclusions: CP-751,871 appears safe and effective in combination with TC. The primary efficacy endpoint (ORR) has been met. Activity observed in squamous cell carcinoma deserves further investigation. ---------------- Quote
CaroleHammett Posted August 9, 2008 Author Posted August 9, 2008 Dr. West at cancergrace.org wrote on this subject on 08/06/08 at http://cancergrace.org/lung/2008/08/06/igf-1r-for-squam-nsclc where you will also find my "frustrated" comment regarding the inavailability to me of this therapy due to requirements for eligibility in the three Clinical Trials of this drug. Carole Quote
CaroleHammett Posted August 9, 2008 Author Posted August 9, 2008 See also news articles re CP751,871 at http://lungevity.org/l_community/viewtopic.php?p=367855 Carole Quote
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