BACKGROUND: Patients with advanced colorectal cancer have a poor prognosis once standard therapies fail. This retrospective study presents the characteristics and outcomes in 144 patients treated in phase I clinical trials. METHODS: We retrospectively reviewed the clinical outcomes in 144 consecutive patients with colorectal cancer referred to the phase I clinic at MD Anderson. RESULTS: Median age was 60 years (range, 35-86 years). The median number of previous systemic therapies was 4 (range, 1-7). The median PFS with the last line of conventional systemic treatment was 12.3 weeks (95% confidence interval [CI], 11.0-14.4); the median PFS of the best phase I treatment was shorter at 8.1 weeks (95% CI, 7.9-8.7 weeks; log-rank test, P < .0001). In the multivariate analysis that included the RMH score, sex (male vs. female, P = .02; hazard ratio [HR], 1.57), hemoglobin (< 10.5 vs. ≥ 10.5 g/dL; P = .03; HR 1.79), and the RMH score (2-3 vs. 0-1; P < .003; HR, 1.85) were significant predictors of poor survival. CONCLUSION: The PFS of patients with colorectal cancer in phase I treatment was shorter than it was on their last line of conventional systemic treatment. Multivariate analysis confirmed the value of the RMH score for predicting overall survival in patients with colorectal cancer enrolled in phase I studies.
BACKGROUND:Patients with advanced colorectal cancer have a poor prognosis once standard therapies fail. This retrospective study presents the characteristics and outcomes in 144 patients treated in phase I clinical trials. METHODS: We retrospectively reviewed the clinical outcomes in 144 consecutive patients with colorectal cancer referred to the phase I clinic at MD Anderson. RESULTS: Median age was 60 years (range, 35-86 years). The median number of previous systemic therapies was 4 (range, 1-7). The median PFS with the last line of conventional systemic treatment was 12.3 weeks (95% confidence interval [CI], 11.0-14.4); the median PFS of the best phase I treatment was shorter at 8.1 weeks (95% CI, 7.9-8.7 weeks; log-rank test, P < .0001). In the multivariate analysis that included the RMH score, sex (male vs. female, P = .02; hazard ratio [HR], 1.57), hemoglobin (< 10.5 vs. ≥ 10.5 g/dL; P = .03; HR 1.79), and the RMH score (2-3 vs. 0-1; P < .003; HR, 1.85) were significant predictors of poor survival. CONCLUSION: The PFS of patients with colorectal cancer in phase I treatment was shorter than it was on their last line of conventional systemic treatment. Multivariate analysis confirmed the value of the RMH score for predicting overall survival in patients with colorectal cancer enrolled in phase I studies.
Authors: Audrey E Kam; Gopichand Pendurti; Umang H Shah; Mohammad H Ghalib; Imran Chaudhary; Jennifer Chuy; Lakshmi Rajdev; Andreas Kaubisch; Santiago Aparo; Ioannis Mantzaris; Sanjay Goel Journal: Invest New Drugs Date: 2018-10-12 Impact factor: 3.850
Authors: Prasanth Ganesan; Filip Janku; Aung Naing; David S Hong; Apostolia M Tsimberidou; Gerald S Falchook; Jennifer J Wheler; Sarina A Piha-Paul; Siqing Fu; Vanda M Stepanek; J Jack Lee; Rajyalakshmi Luthra; Michael J Overman; E Scott Kopetz; Robert A Wolff; Razelle Kurzrock Journal: Mol Cancer Ther Date: 2013-10-03 Impact factor: 6.261
Authors: Bradley R Corr; Marisa Moroney; Jeanelle Sheeder; S Gail Eckhardt; Brandon Sawyer; Kian Behbakht; Jennifer R Diamond Journal: Cancer Date: 2020-07-22 Impact factor: 6.860
Authors: X Liu; G C George; A M Tsimberidou; A Naing; J J Wheler; S Kopetz; S Fu; S A Piha-Paul; C Eng; G S Falchook; F Janku; C Garrett; D Karp; R Kurzrock; R Zinner; K Raghav; V Subbiah; K Hess; F Meric-Bernstam; D S Hong; M J Overman Journal: BMC Cancer Date: 2015-10-16 Impact factor: 4.430