Limits...
Insight into early-phase trials for lung cancer in the United States.

Yang JJ, Wu YL - Chin J Cancer (2015)

Bottom Line: Few data have been published comparing early-phase trials for lung cancer between China and the United States (US).In 2014, a cross-sectional survey was conducted to compare phase 1 trials for lung cancer between the Guangdong Lung Cancer Institute (GLCI), the University of Wisconsin Carbone Cancer Center (UWCCC), and the University of Texas MD Anderson Cancer Center (MDACC).We found that the GLCI had a lower percentage of phase 1 lung cancer trials than the MDACC in December 2014 (23.8% [5/21] vs. 59.8% [28/47], P = 0.006) and the UWCCC in September 2014 (16.7% [3/18] vs. 34.8% [8/23], P = 0.345).

View Article: PubMed Central - PubMed

Affiliation: Guangdong Lung Cancer Institute (GLCI), Guangdong General Hospital (GGH), Guangdong Academy of Medical Sciences (GAMS), Guangzhou, Guangdong, 510080, P.R. China. yangjinji2003@163.com.

ABSTRACT

Introduction: Few data have been published comparing early-phase trials for lung cancer between China and the United States (US). This study was to investigate the differences of phase 1 trials for lung cancer between these two countries.

Methods: In 2014, a cross-sectional survey was conducted to compare phase 1 trials for lung cancer between the Guangdong Lung Cancer Institute (GLCI), the University of Wisconsin Carbone Cancer Center (UWCCC), and the University of Texas MD Anderson Cancer Center (MDACC).

Results: We found that the GLCI had a lower percentage of phase 1 lung cancer trials than the MDACC in December 2014 (23.8% [5/21] vs. 59.8% [28/47], P = 0.006) and the UWCCC in September 2014 (16.7% [3/18] vs. 34.8% [8/23], P = 0.345). Descriptive analyses were performed for early-phase trials conducted by the Cancer Therapy Evaluation Program at the National Cancer Institute (CTEP/NCI), the MDACC, and the Chinese Thoracic Oncology Group (CTONG). There were 149 ongoing early-phase trials in the Department of Investigational Cancer Therapeutics (Phase 1 program) at the MDACC in October 2014. In contrast, no phase 1 trials had been initiated by the CTONG since its establishment in 2007.

Conclusions: These data suggest that a significantly higher percentage of phase 1 trials for lung cancer were conducted in the US than in China. Early-phase oncology trials with robust preclinical data had a higher chance of being approved by the Investigational Drug Branch at the CTEP/NCI. Given the importance of early-phase oncology trials in developing innovative cancer medicines, such studies should be highly encouraged and strategically funded in China.

No MeSH data available.


Related in: MedlinePlus

A recommendation that translational oncology trials should be facilitated by the National Natural Science Funding of China (NSFC) and China Food and Drug Administration (CFDA). INDs investigational new drugs.
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Fig4: A recommendation that translational oncology trials should be facilitated by the National Natural Science Funding of China (NSFC) and China Food and Drug Administration (CFDA). INDs investigational new drugs.

Mentions: The mission of the CTEP is to improve the lives of cancer patients by finding better ways to treat, control, and cure cancer. The CTEP accomplishes this mission by funding an extensive national program of cancer research and by sponsoring clinical trials to evaluate new anti-cancer agents, with a particular emphasis on translational research to elucidate molecular targets and the mechanisms of drug effects. As far as we know, no institution similar to the CTEP exists in China. Without government funding or sponsorship, some promising early-phase oncology trials lost the opportunity to be further academically developed. For example, the CTONG0806 study, a multi-center phase 2 trial, was initiated to explore the efficacy and tolerability of pemetrexed versus gefitinib as a second-line treatment in patients with advanced non-squamous NSCLC harboring wild-type EGFR [27]. The lack of funding or sponsorship led to slower accrual and much more delayed publication of CTONG0806 than two other similar trials [28, 29]. Thus, we suggest that early-phase oncology trials should be funded or sponsored by the National Natural Science Funding of China (NSFC) and CFDA to facilitate the development of innovative anti-cancer agents in China (Figure 4).Figure 4


Insight into early-phase trials for lung cancer in the United States.

Yang JJ, Wu YL - Chin J Cancer (2015)

A recommendation that translational oncology trials should be facilitated by the National Natural Science Funding of China (NSFC) and China Food and Drug Administration (CFDA). INDs investigational new drugs.
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4593356&req=5

Fig4: A recommendation that translational oncology trials should be facilitated by the National Natural Science Funding of China (NSFC) and China Food and Drug Administration (CFDA). INDs investigational new drugs.
Mentions: The mission of the CTEP is to improve the lives of cancer patients by finding better ways to treat, control, and cure cancer. The CTEP accomplishes this mission by funding an extensive national program of cancer research and by sponsoring clinical trials to evaluate new anti-cancer agents, with a particular emphasis on translational research to elucidate molecular targets and the mechanisms of drug effects. As far as we know, no institution similar to the CTEP exists in China. Without government funding or sponsorship, some promising early-phase oncology trials lost the opportunity to be further academically developed. For example, the CTONG0806 study, a multi-center phase 2 trial, was initiated to explore the efficacy and tolerability of pemetrexed versus gefitinib as a second-line treatment in patients with advanced non-squamous NSCLC harboring wild-type EGFR [27]. The lack of funding or sponsorship led to slower accrual and much more delayed publication of CTONG0806 than two other similar trials [28, 29]. Thus, we suggest that early-phase oncology trials should be funded or sponsored by the National Natural Science Funding of China (NSFC) and CFDA to facilitate the development of innovative anti-cancer agents in China (Figure 4).Figure 4

Bottom Line: Few data have been published comparing early-phase trials for lung cancer between China and the United States (US).In 2014, a cross-sectional survey was conducted to compare phase 1 trials for lung cancer between the Guangdong Lung Cancer Institute (GLCI), the University of Wisconsin Carbone Cancer Center (UWCCC), and the University of Texas MD Anderson Cancer Center (MDACC).We found that the GLCI had a lower percentage of phase 1 lung cancer trials than the MDACC in December 2014 (23.8% [5/21] vs. 59.8% [28/47], P = 0.006) and the UWCCC in September 2014 (16.7% [3/18] vs. 34.8% [8/23], P = 0.345).

View Article: PubMed Central - PubMed

Affiliation: Guangdong Lung Cancer Institute (GLCI), Guangdong General Hospital (GGH), Guangdong Academy of Medical Sciences (GAMS), Guangzhou, Guangdong, 510080, P.R. China. yangjinji2003@163.com.

ABSTRACT

Introduction: Few data have been published comparing early-phase trials for lung cancer between China and the United States (US). This study was to investigate the differences of phase 1 trials for lung cancer between these two countries.

Methods: In 2014, a cross-sectional survey was conducted to compare phase 1 trials for lung cancer between the Guangdong Lung Cancer Institute (GLCI), the University of Wisconsin Carbone Cancer Center (UWCCC), and the University of Texas MD Anderson Cancer Center (MDACC).

Results: We found that the GLCI had a lower percentage of phase 1 lung cancer trials than the MDACC in December 2014 (23.8% [5/21] vs. 59.8% [28/47], P = 0.006) and the UWCCC in September 2014 (16.7% [3/18] vs. 34.8% [8/23], P = 0.345). Descriptive analyses were performed for early-phase trials conducted by the Cancer Therapy Evaluation Program at the National Cancer Institute (CTEP/NCI), the MDACC, and the Chinese Thoracic Oncology Group (CTONG). There were 149 ongoing early-phase trials in the Department of Investigational Cancer Therapeutics (Phase 1 program) at the MDACC in October 2014. In contrast, no phase 1 trials had been initiated by the CTONG since its establishment in 2007.

Conclusions: These data suggest that a significantly higher percentage of phase 1 trials for lung cancer were conducted in the US than in China. Early-phase oncology trials with robust preclinical data had a higher chance of being approved by the Investigational Drug Branch at the CTEP/NCI. Given the importance of early-phase oncology trials in developing innovative cancer medicines, such studies should be highly encouraged and strategically funded in China.

No MeSH data available.


Related in: MedlinePlus