Objective: To summarize the evaluation of meta analyses on the correlation between short-term endpoints (ORR, CR, etc.) and final endpoints (PFS, OS) in cancer, and to explore the correlation between different types of cancer. Methods: Based on Cooper et al. (2020), a systematic search in databases of Medline, Embase, the Cochrane library, Web of Science, and CINAHL were updated from March 2019 to January 2022. Meta analyses assessing the individual-level and trial-level correlation between short-term intermediate endpoints and final endpoints are summarized, and subgroup analyses are conducted in terms of the three most common cancer types. Results: The systematic review includes 77 studies across 20 types of cancer, in which non small cell lung cancer (NSCLC), colorectal cancer (CRC), and breast cancer are the three most common cancer types. The included studies mainly analyzed the correlation between ORR and OS (91%) or PFS (35%), and the correlation was week regardless of individual-level and trial-level. In subgroup analyses, over half studies in NSCLC indicated good or excellent trial-level correlation between ORR and PFS (R²>0.4). Also, most studies in NSCLC and CRC indicated that the trial-level correlation between ORR and PFS >0.3, >0.2) was stronger than that between ORR and OS (>0.1, >0.1). Conclusion: The short-term intermediate endpoints, such as ORR, may not be good surrogates for final endpoints. ORR may be a short-term intermediate indicator worth be noticed by regulators, which could be surrogate for PFS in trial-level in the field of NSCLC and CRC, especially in the field of NSCLC.

Objective: To analyze the related substances produced in new production process of somatostatin, and the stability of raw materials and preparation was studied. Methods: The related substances were separated, collected, characterized and analyzed by high performance liquid chromatography, preparative liquid chromatography and ultra performance liquid chromatography-time-of-flight mass spectrometry tandem system. In addition, the stability of somatostatin and its preparation was studied under high temperature, light, oxidation and acidolysis destruction conditions. Conclusion: Based on the stability study combined with the production process of somatostatin and its preparation, somatostatin will produce new impurities in the new production process. This study provides a basis for revising pharmacopoeia standards.