Targeted therapy for intractable cancer on the basis of molecular profiles: An open-label, phase II basket trial (Long March Pathway).

Purpose: We evaluated he effects of molecular guided-targeted therapy for intractable cancer. Also, the epidemiology of druggable gene alterations in Chinese population was investigated. Materials and methods: The Long March Pathway (ClinicalTrials.gov identifier: NCT03239015) is a non-randomized, open-label, phase II trial consisting of several basket studies examining the molecular profiles of intractable cancers in the Chinese population. The trial aimed to 1) evaluate the efficacy of targeted therapy for intractable cancer and 2) identify the molecular epidemiology of the tier II gene alterations among Chinese pan-cancer patients. Results: In the first stage, molecular profiles of 520 intractable pan-cancer patients were identified, and 115 patients were identified to have tier II gene alterations. Then, 27 of these 115 patients received targeted therapy based on molecular profiles. The overall response rate (ORR) was 29.6% (8/27), and the disease control rate (DCR) was 44.4% (12/27). The median duration of response (DOR) was 4.80 months (95% CI, 3.33-27.2), and median progression-free survival (PFS) was 4.67 months (95% CI, 2.33-9.50). In the second stage, molecular epidemiology of 17,841 Chinese pan-cancer patients demonstrated that the frequency of tier II gene alterations across cancer types is 17.7%. Bladder cancer had the most tier-II alterations (26.1%), followed by breast cancer (22.4%), and non-small cell lung cancer (NSCLC; 20.2%). Conclusion: The Long March Pathway trial demonstrated a significant clinical benefit for intractable cancer from molecular-guided targeted therapy in the Chinese population. The frequency of tier II gene alterations across cancer types supports the feasibility of molecular-guided targeted therapy under basket trials.

[Clinical observation on the effect of electroacupuncture of Sanyinjiao (SP 6) on labor].

OBJECTIVE: To observe the effect of electroacupuncture (EA) of Sanyinjiao (SP 6) on labor in parturients. METHODS: A total of 349 parturients were randomly divided into EA (n=117), sham-EA (n=117) and control (n=115) groups. The visual analog scale (VAS) was used to assess the pain intensity of puerperas with labor before and after acupuncture intervention. After excluding those puerperas with cesarean section, the time required for each stage of labor and the total duration of labor were observed in 286 cases of natural delivery women including 92 cases in the control group, 94 cases in the sham-EA group and 100 cases in the EA group. EA (2 Hz/100 Hz, 20 mA) was given to the puerperas for 30 min after the needle in a cannula was tapped into Sanyinjiao(SP 6) and when the dilatation of cervix was about 2-3 cm wide. For puerperas of sham-EA group, the operation was similar, but no real acupuncture needle and no real electric current were given. RESULTS: The VAS score for childbirth pain intensity was significantly lower in EA group than in control group (P < 0.05) and had no significant difference between sham-EA and control group (P > 0.05). The duration of the active phase of the first stage of labor was significantly lower in EA group than in sham-EA group (P < 0.05), but had no significant difference between sham-EA and control groups (P > 0.05). No significant differences were found among the 3 groups in the latency of the first stage of labor, in the duration of the 2nd and the 3rd stages of labor and in the total phase of labor (P > 0.05). CONCLUSION: EA of SP 6 can relieve the pain intensity of the labor and shorten the duration of the active period of first stage of labor in puerperas, suggesting an improvement of the quality of delivery after EA.

[Clinical application of acupuncture and moxibustion to the treatment of gouty arthritis and analysis on their therapeutic effects].

In the present paper, the authors make a summary on the clinical application of acu-moxibustion therapy in the treatment of gouty arthritis in recent 10 years. Acupuncture needles often used are filiform needle, red-hot needle, moxibustion-warmed needle and three-edged needle. Clinical studies have showed that acupuncture therapy has a definite efficacy in relieving gouty arthritis and has its clinical characteristics, such as faster efficacy, lower relapse rate, etc. in comparison with medication.