[Show abstract][Hide abstract] ABSTRACT: Introduction
The aim of this study was to compare the efficacy and toxicity of dicycloplatin plus paclitaxel with those of carboplatin plus paclitaxel as first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC).
Material and methods
In this study, 240 NSCLC patients with stage IIIB (with pleural effusion) and stage IV disease were randomly assigned (1: 1) to receive dicycloplatin 450 mg/m2 or carboplatin AUC = 5, in combination with paclitaxel 175 mg/m2 (D + P or C + P) every 3 weeks for up to 4 to 6 cycles. The primary endpoint was response rate. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and adverse events.
The response rates for the D + P and C + P arm were 36.44% and 30.51%, respectively (p = 0.33). The median PFS was 5.6 months in the D + P arm and 4.7 months in the C + P arm (p = 0.31). The median OS was 14.9 months for D + P and 12.9 months for C + P (p = 0.37). Adverse events in the two arms were well balanced. The most common grade 3/4 adverse event was hematologic toxicity.
Patients treated with D + P had similar response and survival rates to those treated with C + P, and toxicities of both treatments were generally tolerable.
Archives of Medical Science 08/2014; 10(4):717-724. DOI:10.5114/aoms.2014.44862 · 2.03 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This clinical study was designed to evaluate the efficacy and toxicity of the combined regimen of docetaxel, 5-Fu and DDP (TPF) in the treatment of advanced or relapsed nasopharyngeal carcinoma (NPC).
Fifty-six patients with newly diagnosed or recurrent/metastatic NPC following chemotherapy or radiotherapy were enrolled. Both docetaxel and DDP were administered intravenously for 6 hours at the dose of 70 mg/m2 on D1. 5-Fu was given at a dose of 400-500 mg/m2 for 6 hours from D1 to D5. Dexamethasone was routinely administered before injection of docetaxel. This combination was repeated every 3 to 4 weeks, and continued for 4-6 cycles or until PD for the responders.
Fifty-one (91.1%) patients were evaluable for response assessment. The response rate for whole group was 72.5% (37/51) with a CR rate of 9.8% (5/51). The stable disease accounted for 17.6% (9/51). There were 17(30.4%) chemotherapy-naïve patients. The overall response rate in those was 82.4% with a CR rate of 29.4%. However, the response rate for previously treated patients was 64.7% without CR. Twelve patients had progressed disease, including 5 (8.9%) died of disease progression with a median follow-up of 11 month (ranged from 1 to 19 months). Totally, 196 courses of chemotherapy were administered. The major toxicity was myelosupression, nausea/vomiting. The incidence of leucopenia was 48% with 22.2% of these in NCI grade II or IV. But only 2 patients (3.6%) experienced leucopenia with a fever. Other mild toxicities including alopecia, asthenia, mucositis and diarrhea were also observed.
Our preliminary outcome shows docetaxel, 5-Fu and DDP combination is effective and safe for the patients with advanced or relapsed nasopharyngeal carcinoma. But further clinical study is warranted.
Zhonghua zhong liu za zhi [Chinese journal of oncology] 05/2008; 30(4):314-6.
[Show abstract][Hide abstract] ABSTRACT: Nedaplatin is a second-generation anticancer drug containing organic platinum. Clinical researches in overseas showed that Nedaplatin is an anticancer drug with broad spectrum and high efficiency, especially in treating esophageal carcinoma. But the therapeutic efficacy and toxicity of home-produced Nedaplatin in China are unclear. This study was to evaluate the efficacy of home-produced Nedaplatin in China on esophageal carcinoma, and observe its toxicity.
A multi-center, phase II, prospective clinical trial was conducted. Naive patients with esophageal carcinoma were enrolled and randomized into trial group and control group. The patients in trial group were treated with home-produced Nedaplatin plus 5-fluorouracil (5-FU); the patients in control group were treated with cisplatin (DDP) plus 5-FU.
A total of 52 patients were enrolled: 30 in trial group, and 22 in control group. For trial group, therapeutic efficacy was evaluable in 27 cases, and toxicity was evaluable in all cases; for control group, therapeutic efficacy and toxicity were evaluable in all cases. The response rate was significantly higher in trial group than in control group (29.62% vs. 22.72%, P<0.05). The complete remission (CR) rates were 18.51% in trial group and 4.55% in control group. When considering myelosuppression, the occurrence rate of anemia was similar in the 2 groups; but the occurrence rates of neutropenia and thrombocytopenia were higher in trial group than in control group, especially for grade III-IV thrombocytopenia (20.68% vs. 0%, P<0.01). The occurrence rate of gastrointestinal reaction was lower in trial group than in control group. There were no significant differences in hepatotoxicity, renal toxicity, heart toxicity, peripheral nerve toxicity, and alopecia between the 2 groups.
Nedaplatin is an effective platinum drug for esophageal carcinoma. The treatment efficacy of Nedaplatin plus 5-FU regimen is better than that of DDP plus 5-FU regimen. It has a good clinical tolerance. The main toxicity is myelosuppression, and thrombocytopenia is predominant.
Ai zheng = Aizheng = Chinese journal of cancer 01/2007; 25(12):1565-8. · 2.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Two kinds of home-produced docetaxel in China, injection Yiyoutasai and injection Aisu, have the same structure. Data from preclinical study had shown that injection Yiyoutasai has the same pharmacokinetics and toxicity as injection Aisu. This study was to evaluate the efficacy and toxicity of injection Yiyoutasai in treating advanced breast cancer.
Eligible breast cancer patients were enrolled and randomly assigned to study group and control group, and received injection of 75 mg/m(2) Yiyoutasai or Aisu, respectively. The injections were repeated every 3 weeks. All patients received at least 2 cycles. The efficacy of Yiyoutasai and Aisu were evaluated after treatment.
A total of 67 patients were enrolled: 33 in study group, and 34 in control group. Of the 31 evaluable cases in study group, 1 achieved complete remission (CR), 9 achieved partial remission (PR), 11 had stable disease (SD), and 10 had progressive disease (PD); the total response rate was 22.22%. There were 1 CR, 5 PR, 19 SD, and 9 PD in control group; the total response rate was 15.15%. There was no significant difference between the 2 groups (P=0.662). The median follow-up was 16.5 months (8-28 months). In study group, the median progression-free survival time was 6.2 months (2-12 months), the 1-year survival rate was 68.51%, and the 2-year survival rate was 40.12%; in control group, the median progression-free survival time was 7.1 months (2.3-11 months), the 1-year survival rate was 65.23%, and the 2-year survival rate was 39.71%. There was no significant difference between the 2 groups (P=0.102, 0.098, 0.089, respectively). Common adverse events were myelosuppression, transient transaminase elevation, and alopecia. One patient in study group suffered from severe allergic reaction after infusion, 1 in control group suffered from whole body edema.
Yiyoutasai and Aisu have similar efficacy on and toxicity to advanced breast cancer patients.
Ai zheng = Aizheng = Chinese journal of cancer 01/2007; 25(12):1557-60. · 2.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Docetaxel is one of the major drugs for advanced non-small cell lung cancer (NSCLC) treatment in clinical use. It is reported that the response rate of docetaxel alone is about 20% and its major toxicity is myelosuppression. The study was to evaluate the efficacy and tolerability of docetaxel (made in Beijing) in the treatment of advanced NSCLC.
77 patients were randomized into two groups. In the study group, patients were received docetaxel (made in Beijing) 75 mg/m(2) in one hour plus cisplatin 70 mg/m(2); while in the control group, docetaxel (made in Jiangsu) 75 mg/m(2) plus cisplatin 70 mg/m(2) were administrated. Treatment in the two groups was repeated every 3 weeks. All patients had to receive at least two cycles of chemotherapy.
The objective responses in the study and control group were 28.95% and 27.03% respectively, with no statistical difference (P>0.5). Common toxicities of docetaxel (made in Beijing) were grade II-III myelosuppression, grade I-II transaminase elevation, alopecia and hypodynamia.
Docetaxel (made in Beijing) is an effective chemotherapy drug in advanced NSCLC treatment, which has the similar efficacy and toxicity to docetaxel (made in Jiangsu).
Ai zheng = Aizheng = Chinese journal of cancer 08/2006; 25(8):999-1002. · 2.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: H101 is an E1B-55 kDa gene-deleted replication-selective adenovirus, which showed a significant antitumor activity. This study was to compare effects and toxicities of intratumoral H101 injection combined with cisplatin plus 5-fluorouracil (PF) regimen or adriamycin plus 5-fluorouracil (AF) regimen versus PF or AF regimen alone in treating patients with head and neck or esophagus squamous cell cancer.
A total of 160 patients were recruited. PF regimen (cisplatin 20 mg/m(2) ivgtt, qd x 5d; 5-fluorouracil 500 mg/m(2) ivgtt, qd x 5d) was administered to patients have no history of PF chemotherapy,or sensitive to PF chemotherapy,while AF regimen (adriamycin 50 mg/m(2) iv,d1; 5-fluorouracil 500 mg/m(2) ivgtt, qd x 5d) was administered to patients didn't response to PF regimen. All patients were randomized to either receive intratumoral H101 injection (5.0 x 10(11)-1.5 x 10(12) VP/day for 5 consecutive days every 3 weeks) or not. Treatment repeated every 3 weeks,all patients have to receive at least 2 cycles of chemotherapy.
Among 123 accordant patients,overall response rate of PF plus H101 group (group A1) was 78.8% (41/52),of PF alone group (group B1) was 39.6% (21/53),of AF plus H101 group (group A2) was 50.0% (7/14),of AF alone group (group B2) was 50.0% (2/4). Differences of response rates between group A1 and group B1,between group A1+A2 and group B1+B2 were significant (P=0.000). Main side effects were fever (45.7%), injection site reaction (28.3%),and influenza-like symptoms (9.8%).
Intratumoral H101 injection showed a distinct efficacy in patients with squamous cell cancer of head and neck or esophagus,and was relatively safe.
Ai zheng = Aizheng = Chinese journal of cancer 12/2004; 23(12):1666-70. · 2.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: In recent years,great development have been made in cancer therapeutics with replication-competent viruses (oncolytic viruses), E1B deleted adenovirus is one of promising viruses. The current study was designed to evaluate the efficacy and toxicity of intratumoral H101, a E1B-deleted adenovirus, in combination with chemotherapy on patients with cancer.
A total of 50 patients with malignant tumors in multiple centers clinical trial were treated with H101, 0.5ml 5x10(11) viral particle per day for 5 consecutive days every three weeks. Routine chemotherapy was performed at the same time. And the efficacy and toxicity were recorded.
Among 46 valuable cases, the overall response rate was 30.4%. The response rate was 28.0% (14/50) among ITT population, including 3 complete response (CR) and 11 partial response (PR). The overall response rate of control lesion was 13.0%, including 1 case of CR and 5 cases of PR. Thus, the response rate in injected lesion is clearly higher than that in control lesion (P< 0.001). Main side effects were injection site pain (26.9%) and fever (30.2%). Grade 1 hepatic dysfunction was found in 4 patients, grade 2 in 1 patients, grade 4 in 1 patients. Grade 4 hematological toxicities were found in 4 patients.
The study showed that the combination of genetically modified adenovirus (H101) and chemotherapy possessed some effect for treating the patients with refractory malignant tumors, and the toxicities were lower, well tolerated.
Ai zheng = Aizheng = Chinese journal of cancer 01/2004; 22(12):1307-10. · 2.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
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.
Ai zheng = Aizheng = Chinese journal of cancer 01/2004; 22(12):1334-8. · 2.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The aim of this study was to observe the efficacy and the side effects of nedaplatin in treatment of non-small cell lung cancer (NSCLC).
This is a multi-center phase II clinical trial. The previously chemotherapy treated patients with NSCLC were administrated nedaplatin alone. Nedaplatin was given at 100 mg/m2, i.v., repeated every 3 weeks. The chemonaive patients with NSCLC were randomized to two groups. The combination trial group was given with nedaplatin + vindesine regimen, and the combination control group with cisplatin + vindesine.
Of 138 patients, 16 were in the nedaplatin single drug group; 60 were in the combination trial group; and 62 were in the combination control group. All of the 16 cases in the single drug group, which were treated with platinum previously, achieved 12.5% of response rate. And the combination trial group and control group had a very similar response rate, which were 26.7% versus 25.8%, respectively. The incidence rates of neutropenia and anemia were similar in the two groups. But the incidence rate of thrombocytopenia was higher in the trial group than that in the control group. Nedaplatin has a possibility to result in mild nausea/vomiting.
Nedaplatin is an effective platinum drug in the treatment of NSCLC, not only for no previously chemotherapy patients, but also for those patients resistant to cisplatin/carboplatin. Nedaplatin has a good clinical tolerance. And the main adverse reaction was myelosuppression, especially thrombocytopenia.
Ai zheng = Aizheng = Chinese journal of cancer 12/2002; 21(12):1354-8. · 2.16 Impact Factor