Multicenter clinical study for evaluation of efficacy and safety of transdermal fentanyl matrix patch in treatment of moderate to severe cancer pain in 474 chinese cancer patients.

OBJECTIVE: Although a new matrix formulation fentanyl has been used throughout the world for cancer pain management, few data about its efficacy and clinical outcomes associated with its use in Chinese patients have been obtained. This study aimed to assess the efficacy and safety of the new system in Chinese patients with moderate to severe cancer pain. METHODS: A total of 474 patients with moderate to severe cancer pain were enrolled in this study and were treated with the new transdermal fentanyl matrix patch (TDF) up to 2 weeks. All the patients were asked to record pain intensity, side effects, quality of life (QOL), adherence and global satisfaction. The initial dose of fentanyl was 25 µg/h titrated with opioid or according to National Comprehensive Cancer Network (NCCN) guidelines. Transdermal fentanyl was changed every three days. RESULTS: After 2 weeks. The mean pain intensity of the 459 evaluated patients decreased significantly from 5.63±1.26 to 2.03±1.46 (P<0.0001). The total remission rate was 91.29%, of which moderate remission rate 53.16%, obvious remission rate 25.49% and complete remission rate 12.64%. The rate of adverse events was 33.75%, 18.78% of which were moderate and 3.80% were severe. The most frequent adverse events were constipation and nausea. No fatal events were observed. The quality of life was remarkably improved after the treatment (P<0.0001). CONCLUSION: The new TDF is effective and safe in treating patients with moderate to severe cancer pain, and can significantly improve the quality of life.

[Prognostic analysis of stage III-IV non-small cell lung cancer patients treated by traditional chinese medicine].

BACKGROUND & OBJECTIVE: Chemotherapy is a treatment for stage III-IV non-small cell lung cancer (NSCLC), but the efficacy is not ideal. Traditional Chinese medicine (TCM) has certain effect on NSCLC. This study was to investigate various factors that affect the prognosis of advanced NSCLC, and evaluate the role of TCM in enlonging survival time of patients with stage III-IV NSCLC. METHODS: The NSCLC patients who meet the inclusive criteria were randomized into TCM group, combination (TCM plus NP regimen) group, and chemotherapy group, and received relevant treatments. The median survival time (MST) was calculated by Kaplan-Meier method. The prognosis of the patients was analyzed by COX regression method. RESULTS: A total of 294 stage III-IV NSCLC patients were enrolled, of which 99 were in TCM group, 103 in combination group, 92 in chemotherapy group. The MST were 292 days in TCM group, 355 days in combination group, and 236 days in chemotherapy group; the cumulative survival rates were 45.38%, 48.86%, and 42.17%, respectively (P>0.05). Cox regression analysis indicated that therapy, gender, disease course, erythrocyte sedimentation, KPS score, tumor size, and patient's weight were independent prognostic factors of stage III-IV NSCLC. CONCLUSION: Compare with chemotherapy alone, TCM combined with chemotherapy may prolong the survival time of stage III-IV NSCLC patients.

[Preliminary study of lyophilized 10-hydroxycamptothecin in advanced or recurrent malignancies].

BACKGROUND & OBJECTIVE: 10-Hydroxycamptothecin (HCPT) is the inhibitor of topoisomerase I with anti-cancer effectiveness on several solid tumors. TUOXI (lyophilized HCPT) has higher purity and stability in comparison with solution for injection HCPT. The purpose of this study was to investigate the efficacy, toxicity, and proper dosage of TUOXI as single agent in treatment of advanced and recurrent solid tumors. METHODS: Sixty patients with the median age of 53 (range from 17 to 73 years) were enrolled into this multicenter phase II clinical trial. Among them, 18 patients were chemonaive and 42 were recurrent from chemotherapy; 22 patients with NSCLC, 12 nasopharyngeal carcinoma, 9 primary liver cancer, 9 colorectal carcinoma, 2 pancreatic carcinoma, and 6 miscellaneous malignancies. HCPT was given at the dosage of 6-8 mg/m(2) x d for 5-10 consecutive days based on the toxicity. RESULTS: Fifty-one patients were valuable for effectiveness. The objective response rate for the whole group was 15.7%. The partial remission (PR) rates were 16% for 6 mg/m(2) group and 15.4% for 8 mg/m(2) group, respectively. The PR rates were 13.7% (3/22) for NSCLC, 33.3% (3/9) for colorectal carcinoma, and 16.6% (2/12) for advanced nasopharyngeal carcinoma, respectively. The PR rate for 60 intent-to-treat patients was 13.3% (8/60). Myelosuppression was the dose-limiting toxicity and other adverse reactions included nausea/vomiting, diarrhea, and skin rash. The incidence of grade III+IV adverse events were 32%, 8%, 8%, 6%, and 4% for leucopenia, skin rash, thrombocytopenia, nausea/vomiting, and diarrhea, respectively. No renal, pulmonary, and cardiac toxicity were found. CONCLUSION: TUOXI (HCPT lyophilized powder) had relatively broad- spectrum anti-cancer efficacy and was effective on advanced or recurrent NCSLC, colorectal carcinoma, and NPC. And the recommended dosage is 6-8 mg/m(2) as 4 hours infusion for 5-10 consecutive days every 3 weeks. Further clinical investigation on large number of solid tumors cases are warranted.