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Journal of Clinical Oncology | 1997

Gemcitabine versus the combination of cisplatin and etoposide in patients with inoperable non-small-cell lung cancer in a phase II randomized study.

Reury Perng Perng; Yuh-Min Chen; Jacqueline Ming-Liu; Chun-Ming Tsai; Wei Chun Lin; Kuang Yao Yang; Jacqueline Whang-Peng

PURPOSE A phase II randomized study was conducted to evaluate the efficacy and toxicity of gemcitabine (GEM) versus the combination of cisplatin and etoposide (EP) in Chinese patients with inoperable (stage III or IV) non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS From March 1995 to February 1996, 53 patients were enrolled onto the study: 27 onto the GEM arm and 26 onto the EP arm. In the GEM arm, gemcitabine 1,250 mg/m2 was given as a 30-minute intravenous (i.v.) infusion on days 1, 8, and 15 of each 28-day cycle. In the EP arm, cisplatin 80 mg/m2 was given on day 1 and etoposide 80 mg/m2 was given on days 1, 2, and 3 of each 28-day cycle. RESULTS Twenty-six patients are assessable for treatment response on the GEM arm and 24 on the EP arm. Five patients (19.2%) on the GEM arm and five patients (20.8%) on the EP arm achieved a partial response (PR). No complete responses were attained on either treatment arm. All patients enrolled onto the study were eligible for toxicity assessment. The main toxicities were myelosuppression and vomiting, which included World Health Organization (WHO) grade 3 or 4 leukopenia (3.7%), thrombocytopenia (7.4%), anemia (7.4%), and nausea/vomiting (3.7%) on the GEM arm, and WHO grade 3 or 4 leukopenia (30.8%), thrombocytopenia (7.7%), anemia (15.4%), and nausea/vomiting (34.6%) on the EP arm. The median survival time was 37 weeks on the GEM arm and 48 weeks on the EP arm. CONCLUSION Gemcitabine is a well-tolerated chemotherapeutic agent for NSCLC. The antitumor activity was promising, with a 19.2% single-drug response rate, when compared with EP combination chemotherapy, which had a response rate of 20.8%. The safety profile is better than that of EP treatment.


Journal of Medical Ethics | 1999

The status of the do-not-resuscitate order in Chinese clinical trial patients in a cancer centre.

Jacqueline Ming Liu; Wei Chun Lin; Yuh-Min Chen; Hsiao Wei Wu; Nai Shun Yao; Li-Tzong Chen; Jacqueline Whang-Peng

OBJECTIVE: To report and analyse the pattern of end-of-life decision making for terminal Chinese cancer patients. DESIGN: Retrospective descriptive study. SETTING: A cancer clinical trials unit in a large teaching hospital. PATIENTS: From April 1992 to August 1997, 177 consecutive deaths of cancer clinical trial patients were studied. MAIN MEASUREMENT: Basic demographic data, patient status at the time of signing a DNR consent, or at the moment of returning home to die are documented, and circumstances surrounding these events evaluated. RESULTS: DNR orders were written for 64.4% of patients. Patients in pain (odds ratio 0.45, 95% CI 0.22-0.89), especially if requiring opioid analgesia (odds ratio 0.40, 95% CI 0.21-0.77), were factors associated with a higher probability of such an order. Thirty-five patients were taken home to die, a more likely occurrence if the patient was over 75 years (odds ratio 0.12, 95% CI 0.04-0.34), had children (odds ratio 0.14, 95% CI 0.02-0.79), had Taiwanese as a first language (odds ratio 6.74, 95% CI 3.04-14.93), or was unable to intake orally (odds ratio 2.73, 95% CI 1.26-5.92). CPR was performed in 30 patients, none survived to discharge. CONCLUSIONS: DNR orders are instituted in a large proportion of dying Chinese cancer patients in a cancer centre, however, the order is seldom signed by the patient personally. This study also illustrates that as many as 20% of dying patients are taken home to die, in accordance with local custom.


American Journal of Clinical Oncology | 2002

Phase II study of docetaxel and gemcitabine combination chemotherapy in non-small-cell lung cancer patients failing previous chemotherapy.

Yuh-Min Chen; Reury Perng Perng; Wei Chun Lin; Hsiao Wei Wu; Chun-Ming Tsai; Jacqueline Whang-Peng

We conducted a phase II study of docetaxel and gemcitabine chemotherapy in patients with non–small-cell lung cancer (NSCLC) who had not responded to previous chemotherapy, to assess the response to and toxicity of this combination chemotherapy. Thirty-six patients were enrolled from June 1999 to December 1999. Treatment consisted of docetaxel 30 mg/m2 and gemcitabine 800 mg/m2 intravenous infusion on days 1 and 8 every 3 weeks. One hundred forty-six cycles of treatment were given, with a median of four cycles (range, 1–8 cycles). All patients were evaluable for toxicity profile and response rate. The major toxicity was myelosuppression. Grade III or IV neutropenia occurred in 9 patients (25%) during treatment. Febrile neutropenia occurred in 2 patients (5.6%). Grade III or IV thrombocytopenia occurred in 6 patients (16.7%). Reversible fluid retention occurred in 9 patients (25%). Grade IV pulmonary toxicity (interstitial pneumonitis) occurred in two patients, and both died. Other toxicities were few and mild in severity. After two cycles of treatment, 13 patients (36.1%) had a partial response (95% CI 20.3–51.9%). There was no significant difference in the response rate among patients who had responded to previous chemotherapy or not. The median time to disease progression was 3.8 months, and the median survival was 6.9 months. Median survival was 7.1 and 4.9 months in patients receiving docetaxel and gemcitabine as second-line and greater than or equal to third-line chemotherapy, respectively. In conclusion, docetaxel and gemcitabine salvage chemotherapy produces a high response rate and a relatively mild toxicity profile in NSCLC. However, the issue of interstitial pneumonitis should be of concern.


Lung Cancer | 2000

Phase II study of tamoxifen, ifosfamide, epirubicin and cisplatin combination chemotherapy in patients with non-small cell lung cancer failing previous chemotherapy

Yuh-Min Chen; Reury Perng Perng; Kuang Young Yang; Wei Chun Lin; Hsiao Wei Wu; Chun-Ming Tsai; Jacqueline Whang-Peng

We conducted a phase II study of tamoxifen, ifosfamide, epirubicin, and cisplatin (TIEP) chemotherapy in patients with non-small cell lung cancer (NSCLC) who had failed previous chemotherapy, in order to assess the response and toxicity of TIEP. Between November 1997 and May 1999, 25 patients were treated. Twelve of the 25 patients (48%) had been previously treated with cisplatin-based combination chemotherapy. TIEP doses were tamoxifen 60 mg oral twice daily on days 1-3; ifosfamide 2.4 g/m(2) intravenous infusion (IV) 60 min with mesna on day 2; epirubicin 40 mg/m(2) IV bolus on day 2; and cisplatin 50 mg/m(2) IV 60 min on day 2 every 4 weeks for up to six cycles. Seventy one cycles were given to 25 patients, with a median of three cycles (range one to six cycles). All patients were evaluable for toxicity profile and response rate. As expected, the major toxicity was myelosuppression. Grade 3 or 4 neutropenia occurred in 15 patients (60%) during treatment, as well as in 31% of the total courses. Febrile neutropenia occurred in two patients. No toxic death occurred in this study. Grade 3 thrombocytopenia occurred in five patients with five cycles. Toxicities other than myelosuppression were few and mild in severity. After two cycles of treatment, five of 25 patients (20%) had a partial response (95% confidence interval 4.3-35.7%). Among 12 patients previously treated with cisplatin-based chemotherapy, three patients (25%) achieved a partial response. The median time to disease progression was 4.9 months and median survival was 7.7 months. The response rate and median survival were better than in our previous study of salvage chemotherapy with ifosfamide, 5-FU, and leucovorin; and with ifosfamide, epirubicin, 5-FU, and leucovorin. In conclusion, TIEP appears to be an active combination regimen with an acceptable toxicity profile in Chinese patients with NSCLC who have failed previous chemotherapy.


American Journal of Clinical Oncology | 2003

Phase II Study of Gemcitabine and Vinorelbine Combination Chemotherapy in Patients with Non-Small-Cell Lung Cancer Not Responding to Previous Chemotherapy

Yuh-Min Chen; Reury Perng Perng; Chia San Lee; Wei Chun Lin; Chun-Ming Tsai; Jacqueline Whang-Peng

Both gemcitabine and vinorelbine are new anticancer drugs that have shown activity in the treatment of chemonaïve non–small-cell lung cancer (NSCLC). Their role in the second-line treatment of NSCLC is less clear. We conducted a phase II study of gemcitabine and vinorelbine combination chemotherapy in patients with NSCLC who had not responded to previous platinum-based chemotherapy, to assess the response and toxicity of this regimen. Seventeen patients were enrolled from September 1998 to February 2001. Treatment consisted of vinorelbine 20 mg/m2 and gemcitabine 800 mg/m2 intravenous infusion on days 1, 8, and 15 every 4 weeks. Sixty-five cycles of treatment were given, with a median of four cycles. All patients were evaluable for the toxicity profile, and 16 patients were evaluable for the response rate. The major toxicity was myelosuppression. Grade III or IV neutropenia occurred in 9 patients (52.9%) during treatment. Febrile neutropenia occurred in only 1 patient (5.9%). Grade III anemia and thrombocytopenia occurred in two and three patients, respectively. Other toxicities were few and mild in severity. After 2 cycles of treatment, 5 of 16 patients (31.3%) had a partial response (95% CI 8.6–64%). The median time to disease progression was 4.6 months and the median survival was 8.3 months. The 1-year survival rate was 34.3%. In conclusion, gemcitabine and vinorelbine salvage chemotherapy produces a relatively high response rate, low toxicity profile, and good survival in Chinese patients with NSCLC who have not responded to previous platinum-based chemotherapy. Further study is needed to confirm its activity.


Lung Cancer | 2000

Phase II study with gemcitabine, ifosfamide and cisplatin in advanced non-small cell lung cancer

Yuh-Min Chen; Reury Perng Perng; Jacqueline Whang-Peng; Hsiao Wei Wu; Wei Chun Lin; Chun-Ming Tsai

The aim of the present study was to determine the clinical activity and toxicity of a novel chemotherapy combination regimen of gemcitabine, ifosfamide and cisplatin (GIP), administered every 3 weeks, in patients with inoperable non-small cell lung cancer (NSCLC). From October 1998 to July 1999, 18 previously untreated stages IIIb (4) and IV (14) patients were enrolled into the study. Gemcitabine and ifosfamide (with mesna as uroprotection) was administered on days 1 and 6, at a dose of 1000 and 1500 mg/m2, respectively; and cisplatin was given on day 1 at a dose of 60 mg/m2, every 3 weeks. All 18 patients were evaluable for response and toxicity profiles. One patient achieved a complete response, and II patients achieved a partial response, with an overall response rate of 66.7% (95%, CI, 45-89%). The main toxicity was hematological, a NCI grade 3-4 neutropenia in 16 patients (88.9%) during the treatment course. Febrile neutropenia occurred in three patients (16.6%). Grade 3 anemia occurred in eight patients (44.41%) and grade 3-4 thrombocytopenia occurred in 11 patients (61.1%). Non-hematological toxicity was mild and tolerable. No toxic death occurred. The median survival was 12.7 months and 1 year survival was 58.4%. The GIP combination chemotherapy produced a high response rate in advanced NSCLC; however, there was a relatively high percentage of hematological toxicity that still could be tolerated. A randomized trial comparing GIP to a two-drug combination of gemcitabine and cisplatin is planned.


Pancreas | 2002

Palliative MEFLEP therapy in advanced pancreatic cancer: excellent response in a patient with Her-2/neu amplification.

Yee Chao; Jacqueline Ming Liu; Anna Fen Yau Li; Ching Lin Perng; Chue Mei Tiu; Kuan Liang King; Li-Tzong Chen; Wei Chun Lin; Chieh Lan; Jacqueline Whang-Peng

Introduction Patients with pancreatic cancer often present initially in advanced disease with many compromising factors, and yet they may still be responsive to chemotherapy. Aims The response of 23 patients with advanced pancreatic cancer to continuous infusion therapy was investigated. Methodology From September 1995 to February 1998, 23 patients with advanced pancreatic cancer, many with compromising factors, were treated with a MEFLEP regimen: biweekly 24-hour infusions of etoposide, 5-fluorouracil, leucovorin, epirubicin, and cisplatin, all given through an infusion pump, plus megestrol acetate, 160 mg/d, taken daily. A total of 145 courses were given. Overall response rate was 21% (4/19) for assessable chemo-naive patients; median survival for all 23 patients was 6 months; 22% of patients were alive at 1 year; and a clinical response benefit was attained in 35%. Results Toxicity was manageable; grade 3 or 4 leukopenia occurred in 1 patient each, 1 patient had fever and grade 3 infection, and grade 3 and 4 hyperammonemic encephalopathy developed in 3 and 1 patients, respectively. All four of the latter patients recovered uneventfully within 2 days of initiation of therapy. Nine patients were evaluated by fluorescence in situ hybridization for the Her-2/ neu oncogene, but for only one patient did amplification of the gene occur. She attained complete remission with treatment and lived for 26.7 months after diagnosis. Conclusion Biweekly MEFLEP is an active and manageable regimen for patients with advanced pancreatic cancer with compromised clinical status.


Cancer Chemotherapy and Pharmacology | 2002

Phase II and pharmacokinetic study of GL331 in previously treated Chinese gastric cancer patients

Jacqueline Ming Liu; Li-Tzong Chen; Yee Chao; Anna Fy Li; Chew Wen Wu; Tai-Shun Liu; Her Shiong Shiah; Jang Yang Chang; Jong Dong Chen; Hsiao Wei Wu; Wei Chun Lin; Chieh Lan; Jacqueline Whang-Peng


Japanese Journal of Clinical Oncology | 1997

Phase II Study of Ifosfamide and Etoposide Chemotherapy for Extensive-Disease Small-Cell Lung Cancer

Yuh-Min Chen; Ming Fang Wu; Reury Perng Perng; Chi Ming Chou; Kuang Young Yang; Wei Chun Lin; Chun-Ming Tsai; Jacqueline Ming Liu; Jacqueline Whang-Peng


National Medical Journal of China | 2000

Combination chemotherapy with tamoxifen, ifosfamide, epirubicin and cisplatin in extensive-disease small-cell lung cancer

Chen Ym; Reury Perng Perng; Yang Ky; Hsiao Wei Wu; Wei Chun Lin; Jacqueline Ming Liu; Chun-Ming Tsai; Jacqueline Whang-Peng

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Jacqueline Whang-Peng

National Health Research Institutes

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Chun-Ming Tsai

Taipei Veterans General Hospital

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Reury Perng Perng

Taipei Veterans General Hospital

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Yuh-Min Chen

Taipei Veterans General Hospital

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Hsiao Wei Wu

National Health Research Institutes

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Jacqueline Ming Liu

National Health Research Institutes

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Li-Tzong Chen

National Health Research Institutes

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Chieh Lan

National Health Research Institutes

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Yee Chao

Taipei Veterans General Hospital

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Ching Lin Perng

National Yang-Ming University

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