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https://doi.org/10.1038/s41416-023-02193-2
Title: | Clinical outcome and prognostic factors for Asian patients in Phase I clinical trials | Authors: | Loh, Jerold Wu, Jiaxuan Chieng, Jenny Chan, Aurora Yong, Wei-Peng Sundar, Raghav Lee, Soo-Chin Wong, Andrea Lim, Joline SJ Tan, David SP Soo, Ross Goh, Boon-Cher Tai, Bee-Choo Chee, Cheng E |
Keywords: | Science & Technology Life Sciences & Biomedicine Oncology ONCOLOGY TRIALS CANCER-PATIENTS SURVIVAL BENEFITS RISKS SCORE PARTICIPANTS MANAGEMENT CONTEXT PROGRAM |
Issue Date: | 16-Feb-2023 | Publisher: | SPRINGERNATURE | Citation: | Loh, Jerold, Wu, Jiaxuan, Chieng, Jenny, Chan, Aurora, Yong, Wei-Peng, Sundar, Raghav, Lee, Soo-Chin, Wong, Andrea, Lim, Joline SJ, Tan, David SP, Soo, Ross, Goh, Boon-Cher, Tai, Bee-Choo, Chee, Cheng E (2023-02-16). Clinical outcome and prognostic factors for Asian patients in Phase I clinical trials. BRITISH JOURNAL OF CANCER 128 (8). ScholarBank@NUS Repository. https://doi.org/10.1038/s41416-023-02193-2 | Abstract: | Background: Patient selection is key in Phase I studies, and prognosis can be difficult to estimate in heavily pre-treated patients. Previous prognostic models like the Royal Marsden Hospital (RMH) score or using the neutrophil–lymphocyte ratio (NLR) have not been validated in current novel therapies nor in the Asian Phase I population. Methods: We conducted a retrospective review of 414 patients with solid tumours participating in Phase I studies at our centre between October 2013 and December 2020. Results: The RMH model showed poorer prognosis with increasing scores [RMH score 1, HR 1.28 (95% CI: 0.96–1.70); RMH score 2, HR 2.27 (95% CI: 1.62–3.17); RMH score 3, HR 4.14 (95% CI: 2.62–6.53)]. NLR did not improve the AUC of the model. Poorer ECOG status (ECOG 1 vs. 0: HR = 1.59 (95% CI = 1.24–2.04), P < 0.001) and primary tumour site (GI vs. breast cancer: HR = 3.06, 95% CI = 2.16–4.35, P < 0.001) were prognostic. Conclusions: We developed a NCIS prognostic score with excellent prognostic ability for both short-term and longer-term survival (iAUC: 0.71 [95% CI 0.65–0.76]), and validated the RMH model in the largest Asian study to date. | Source Title: | BRITISH JOURNAL OF CANCER | URI: | https://scholarbank.nus.edu.sg/handle/10635/239258 | ISSN: | 0007-0920 1532-1827 |
DOI: | 10.1038/s41416-023-02193-2 |
Appears in Collections: | Staff Publications Elements |
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