阿那莫林肺癌晚期效果怎么样？

Cancer cachexia is a common complication in cancer patients, with a higher incidence rate in gastric cancer and lung cancer, accounting for about 20% of the causes of death in cancer patients. Growth hormone releasing peptide analog (Anamorelin) was developed by Ono Pharmaceutical Co., Ltd. of Japan. The Chinese name of Anamorelin is Anamorelin hydrochloride. It is a new type of oral, non-steroidal growth hormone releasing peptide analog. It will be launched in January 2021. It was approved by the Japan Drug and Medical Devices Administration on March 22 and is suitable for the treatment of cancer cachexia in patients with unresectable late-stage or recurrent gastric cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer and other malignant tumors. So, what is the late-stage effect of Anamorelin in lung cancer?

What is the effect of Anamorelin in the late stage of lung cancer?

Anamorelin is currently the only drug proven to alleviate the progression of cancer cachexia in multiple phase III studies. ROMANA 1 (NCTO1387269) and ROMANA 2 (NCT01387282) are two randomized, double-blind, controlled phase III clinical trials conducted at 93 sites in 19 countries. They mainly screen patients with inoperable stage III or IV non-small cell lung cancer and cachexia.

From 2011 to 2014, ROMANA 1 enrolled 484 patients, and from 2011 to 2013, ROMANA2 enrolled a total of 495 patients. The patients were classified according to their geographical area, cancer treatment status and weight loss in the past 6 months. They were randomly divided into two groups by computer: the Anamorelin treatment group and the placebo control group. The ratio of the number of patients was 2:1. The treatment group received Anamorelin 100 mg orally, once a day. Co-primary efficacy endpoints were changes in lean body mass (LBM) and hand grip strength (HGS) after 12 weeks. After 12 weeks of treatment, compared with the control group, the LBM of the treatment group was significantly improved (ROMANA1: 0.99 kg vs -0.47 kg, P<0.001; ROMANA2: 0.65 kg vs -0.98 kg, P<0.001), but the change in HCS was not obvious.

Conclusion

Compared with placebo, Anamorelin can promote anabolism and increase appetite, and improve patients' lean body mass, fat mass and symptoms, which is consistent with its mechanism of action as a growth hormone-releasing peptide (Chrelin) receptor agonist. In these two trials, there was no significant difference in the occurrence of grade 3 to 4 treatment groups. The most common grade 3 to 4 adverse event was hyperglycemia, and the incidence rate was low, no more than 1%.

References

[1] Gong Weiliang, Li Xiufeng, Zuo Pengli. Research progress on ghrelin analogue anamulin [J]. Drug Evaluation, 2022, 19(19): 1153-1156.DOI: 10.19939/j.cnki.1672-2809.2022.19.01.

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