Gemcitabine Combination Chemotherapy Research Articles

Long-term survival following metachronous intratumoral hemorrhage in an HIV-infected patient with lung cancer

Human immunodeficiency virus (HIV)-infected patients are likely to develop intracranial events. Due to the spread of highly active antiretroviral therapy (HAART), HIV-infected patients now survive longer, and metastatic non-AIDS-defining carcinoma is increasing. A 49-year-old man with HIV infection undergoing treatment with HAART developed an intratumoral hemorrhage in the right frontal lobe. He was diagnosed as having lung adenocarcinoma and was found to have a brain metastasis with bleeding. After treatment for intratumoral bleeding, a contralateral frontal lobe hemorrhage occurred within a month. The patient underwent a second craniotomy and removal of hematoma, followed by whole-brain radiotherapy. He was then treated with four cycles of cisplatin and gemcitabine combination chemotherapy while receiving HAART. A partial response was achieved, though he developed severe hematological toxicities for which the doses of chemotherapy needed to be decreased. However, as a result of treatment, his activities of daily life recovered gradually. This lung cancer patient had been alive for 17months despite the coexistence of two disorders with a poor prognosis, HIV infection and bleeding brain metastases from lung cancer. This case revealed that physicians must include non-AIDS-defining cancer metastasis to the brain in the differential diagnosis of HIV-infected patients when they show stroke-like symptoms, and such patients may respond to treatment as well as non-HIV-infected patients with advanced lung cancer.

Cisplatin–gemcitabine therapy in metastatic breast cancer: Improved outcome in triple negative breast cancer patients compared to non-triple negative patients

Triple negative or basal-like breast cancers lack expression of estrogen, progesterone and HER2 neu receptors. There are no specific treatment guidelines for this group of patients, however, it has been postulated that their phenotypic and molecular similarity to BRCA-1 related cancers would confer sensitivity to certain cytotoxic agents like cisplatin (CDDP). The aim of the study was to retrospectively examine the clinical outcome at our institution of patients with metastatic breast cancer treated with CDDP and gemcitabine combination chemotherapy who had triple negative breast cancer compared to non-triple negative breast cancer. Thirty-six patients with metastatic breast cancer were treated with CDDP and gemcitabine combination chemotherapy, 17 of whom were triple negative (47%) and 19 were non-triple negative (53%). The median progression free survival for triple negative and non-triple negative metastatic breast cancer patients were 5.3 months and 1.7 months respectively ( p = 0.058). By multivariate Cox proportional hazard model after adjusting for age, race and menopausal status the risk of progression was reduced by 47% for triple negative compared to non-triple negative metastatic breast cancer patients (HR = 0.53, p = 0.071). Conclusions Our results suggest an improved outcome for metastatic triple negative breast cancer patients compared to non-triple negative breast cancer patients when treated with cisplatin and gemcitabine combination chemotherapy.

Complete response to FOLFOX4 therapy in a patient with advanced urothelial cancer: a case report

No standard has been established for salvage therapy in gemcitabine refractory advanced urothelial cancer. We report the complete response to FOLFOX4 therapy of a metastatic urothelial cancer patient, for whom adjuvant gemcitabine plus cisplatin combination chemotherapy had failed. A 54-year-old male patient with urothelial cancer (transitional cell carcinoma) in the right kidney underwent three rounds of adjuvant gemcitabine-cisplatin chemotherapy after extensive radical nephrectomy. However, he had new liver, lung metastases and synchronous two separate primary colon cancer. The lung metastasis lesion was confirmed as a metastatic urothelial cancer via percutaneous transthoracic needle biopsy (PTNB). Liver and lung metastasis lesions disappeared after the 4th cycle of FOLFOX4 chemotherapy. In addition, colon cancer also disappeared after the 8th cycle of FOLFOX4 chemotherapy. The patient was still showing a complete response after 4 months. Clinical trials using the FOLFOX regimen as salvage therapy for gemcitabine-refractory advanced urothelial cancer are warranted.

Phase 2 Trial of Docetaxel, Gemcitabine, and Oxaliplatin Combination Chemotherapy in Platinum- and Paclitaxel-Pretreated Epithelial Ovarian Cancer

This phase 2 trial was designed to evaluate the efficacy and toxicity of a combination of docetaxel, gemcitabine, and oxaliplatin for platinum- and paclitaxel-pretreated epithelial ovarian cancer. Heavily pretreated patients (N = 30; median age, 61 years) received docetaxel, 55 mg/m2; gemcitabine, 500 mg/m2 (day 1); and oxaliplatin, 70 mg/m2 (day 2) biweekly. Twelve patients had platinum-sensitive disease, and 18 patients had platinum-resistant disease. Median follow-up was 18.6 months. No differences in patient characteristics were observed between patients with carboplatinum-sensitive and carboplatinum-resistant disease. In patients with carboplatin-sensitive disease, an overall response (OR) of 83.3%, a progression-free survival of 10.6 months, and an overall survival of 18.9 months were observed. In patients with carboplatinum-resistant disease, an OR was seen in 38.9% with a progression-free survival of 5.3 months and an overall survival of 16.3 months. Patients with platinum-refractory disease (progression under previous carboplatinum therapy, n = 13) had an OR of 23%, whereas patients with objective response but relapse less than 6 months after carboplatinum therapy had an OR of 80.0%. Grade 3 and 4 toxicities were only observed for anemia (6.7%), neutropenia (20.0%), thrombopenia, peripheral neuropathy, and diarrhea (16.7%). No neutropenic fever or treatment-related death occurred. In comparison with current standard protocols, a combination of docetaxel, gemcitabine, and oxaliplatin showed considerably higher efficacy without remarkable increased toxicity; particularly for patients with early relapse after a platinum-containing therapy.

6631 Gemcitabine and Oxaliplatine combination chemotherapy for metastatic well differentiated neuroendocrine carcinomas: a single-centre experience

Grâce à une organisation histologique particulière, le foie permet l’assimilation de la plupart des nutriments et l’élimination des éléments toxiques ou pathogènes provenant du tractus digestif. Par ailleurs, la synthèse hépatique de la bile autorise l’absorption des lipides. Le foie joue aussi un rôle important dans de nombreuses fonctions physiologiques car c’est un lieu de synthèse et/ou de stockage majeur pour de nombreux éléments, notamment des protéines, des glucides, des vitamines et des ions.

Gemcitabine and oxaliplatin combination chemotherapy for metastatic well‐differentiated neuroendocrine carcinomas

Beyond the usual regimens based on streptozocin and doxorubicin or 5-fluorouracil, no second-line therapy of metastatic neuroendocrine tumor has gained wide acceptance. Gemcitabine and oxaliplatin are generally well tolerated and have shown activity against a wide range of malignancies. The authors assessed the efficacy of gemcitabine-oxaliplatin combination (GEMOX) in the treatment of patients with metastatic neuroendocrine tumors. Twenty consecutive patients with progressive disease were treated with GEMOX, in most cases after failure of other chemotherapy regimens (median=2). Patients were followed for evidence of toxicity, response, and survival. Two patients were chemotherapy-naive at treatment initiation and were excluded from the efficacy analysis. Toxicity was manageable overall; however, 6 (30%) patients had to discontinue treatment because of oxaliplatin-induced neurotoxicity (grade 2). Three (17%) of 18 patients had a partial response, median progression-free survival was 7.0 months, and median overall survival was 23.4 months. Gemcitabine-oxaliplatin combination shows interesting activity and is well tolerated in pretreated patients with neuroendocrine tumors.

Fixed dose rate infusion of gemcitabine and UFT combination chemotherapy in patients with advanced biliary cancer

e15581 Background: Biliary cancer is diagnosed at advanced stage and recurrence is common after surgical resection. Gemcitabine and UFT combination chemotherapy showed promising results in advanced pancreatic cancer(APC) and fixed dose- rate(FDR) infusion(10mg/m2/min) of gemcitabine is more effective than 30min-infusion in APC patients. We conducted a prospective multicenter phase II study to evaluate the efficacy and toxicity of FDR gemcitabine and UFT combination chemotherapy in advanced biliary cancer(ABC) patients. We evaluated the quality of life(QOL) and relationship between treatment outcome and polymorphisms of DNA repair gene such as RecQ1, RAD54L, XRCC1 and ATM. Methods: We included the chemo-naive patients with measurable metastatic or recurrent biliary adenocarcinoma except gall bladder cancer. Patients received gemcitabine infusion of rate of 10mg/m2/min on day 1, 8, and 15 plus oral UFT (400mg/m2) on day 1 to 21. We used modified PCR-RFLP method to evaluate the polymorphism of DNA repair gene. The primary endpoint was response rate. Results: From October 2006 to March 2008, 47 patients were enrolled and 33 of them were included in this analysis. Median age was 58 years(range 33–73 years) and 18 patients were male. Partial response was 24.2% and disease control rate was 51.5%. The estimated median time to progression(TTP) was 87 days(95% CI 51–123). Median overall survival was 243 days(95% CI 114–372). Grade 3/4 neutropenia was observed in 12 of 33 patients(36.4%) and 17 times of 114 cycles of chemotherapy(14.9%). No febrile neutropenia was observed. Grade 3/4 thrombocytopenia occurred in 5 patients(15.2%). Non-hematologic toxicities were mild. Polymorphism of XRCC1 was related to TTP(TTP of wild, heterozygous variant and homozygous variant type was 162, 71 and 25 days, respectively. p=0.0039). QOL as a secondary endpoint was not analyzed at this time. Conclusions: FDR infusion of gemcitabine and UFT combination chemotherapy in chemo-naïve patients with ABC is a well-tolerated and effective regimen. No significant financial relationships to disclose.

Phase II trial of neoadjuvant fixed dose rate (FDR) gemcitabine with capecitabine (GX) combination chemotherapy in locally advanced pancreatic adenocarcinoma (LAPA)

e15553 Background: To determine the efficacy and safety of fixed dose rate (FDR) gemcitabine and capecitaibne (GX) combination chemotherapy for locally advanced pancreatic adenocarcinoma Methods: Patients with histologically confirmed LAPA were eligible for this prospective phase II trial. Dynamic pancreas/pelvic CT, MRI and FDG-PET were undertaken to assess the resectability. EUS was also performed as needed basis. ‘Borderline resectable (BR)’ and ‘unresectable (UR)’ criteria developed by our pancreatico-biliary multidisciplinary management team (PBMMT) and NCCN criteria were used. After confirmation of resectability, patients received 3 cycles of FDR gemcitabine 1,250 mg/m2 on D1 and D8 and capecitabine 950 mg/m2 from D1-D14 every 3 weeks. Thereafter, staging was repeated and patients underwent surgery if the disease was not unresectable. For patients with R0 resection, additional 6 cycles of GX were administered. For patients with R1 resection, chemoradiotherapy (CRT) (54 Gy over 5 weeks with concurrent 5-FU and leucovorin or capecitabine) followed by FDR-GX was administered. Patients with stable or better response to chemotherapy but assessed unresectable at reassessment received additional chemotherapy up to 9 cycles followed by CRT. Results: Between August 2006 and July 2008, 38 eligible patients (14 with BR and 24 with UR based on NCCN criteria; 29 with BR and 9 with UR based on our PBMMT criteria) entered on this study. The median age was 61 yo (42–76) and 71% had cT4 disease. The response to neoadjuvant chemotherapy was PR in 6 (16%), SD in 26 (68%) and PD in 3 (8%). Metabolic response was achieved in 20 patients (53%) with 2 metabolic CR out of 31 evaluable patients. Grade 3 or worse adverse effects were mainly HFS (n=5) and gastrointestinal (n=3) with no grade 4 in severity. Surgery was performed in 9 patients (24.0%, R0=8, R1=1, 6 in NCCN-BR and 3 in NCCN-UR, 9 in PBMMT-BR) and five patients refused surgery although their diseases seemed not to be unresectable. The median PFS was 9.4 months (95% CI, 8.3–10.4) and estimated median OS was 13.5 months (95% CI, 12.4- 14.5). Conclusions: FDR-GX was effective as neoadjuvnat chemotherapy in LAPA with favorable toxicity profile. No significant financial relationships to disclose.

A pilot phase I/II study of combination chemotherapy with nafamostat mesilate and gemcitabine for unresectable pancreatic cancer

e15600 Background: To improve chemoresistance of gemcitabine (GEM) caused by GEM-induced nuclear factor kappa B (NF- κB) activation, we have conducted combination chemotherapy of GEM with NF-κB inhibitor, nafamostat mesilate (NAM) which is commercially approved as an effective therapeutic agent for disseminated intravascular coagulation, systemic response syndrome, or pancreatitis in Japan for patients with unresectable pancreatic cancer patients through phase 1/2 study. Methods: Study treatment consists of GEM 1,000 mg/m2 on d 8, 15 and 22 plus NAM 2.4∼4.8 mg/kg on d 8, 15 and 22. NAM was administered intra-arterially by continuous regional infusion for 24 hours via an infusion port system one hour before administration of GEM. Overall survival, response rate (RECIST), serum CA19–9 and clinical benefit response (body weight, pain alleviation) were assessed. Results: Between Feb 2007 and Oct 2008, 20 patients with unresectable pancreatic cancer were included in this study. Pts characteristics: male/female: 18/2, median age 63.5 (range 38–79) yrs, median Karnofsky PS 80% (range 70–90%), stage III/IV: 8/12, serum CA19–9 4,662 U/ml (range 88–32,100), baseline visual analogue scale 0–1/2–4/5–7/8–10; 9/4/7/0, baseline analgesic consumption (morphine-equivalent, mg/day) 0/10–100/100>; 10/7/3. The combination of NAM with GEM is well tolerated and MTD has not been reached. The recommended dose was GEM 1,000 mg/m2; NAM 4.8 mg/kg. Overall survival was 8.0 (range 4.7–17) months. CR/PR/NC/PD/not evaluated; 0/3/14/2/1. Serum CA19–9 reduction rate; 89%. Three pts. could become off and 1pt. could reduce oral morphine sulfate, and 5 pts. gained weight. Conclusions: The GEM/NAM regimen is safe, and the clinical data, including overall survival and clinical benefit response, suggest that the initial clinical outcome of this trial has been encouraging. An expanded cohort of the combination chemotherapy is underway. No significant financial relationships to disclose.

Cisplatin plus Gemcitabine Chemotherapy in Taxane/Anthracycline-Resistant Metastatic Breast Cancer

Background: The most commonly used chemotherapeutic regimens in the treatment of metastatic breast cancer (MBC) include anthracyclines and taxanes. In our study, we investigated the efficacy and tolerability of cisplatin plus gemcitabine combination chemotherapy regimen in patients with MBC, who exhibited disease progression after anthracycline- and taxane-based chemotherapy. Methods: Thirty-three patients with taxane/anthracycline-resistant MBC have been treated with gemcitabine 1,000 mg/m² intravenously and cisplatin 30 mg/m² intravenously on days 1 and 8 of a 3-week treatment cycle. Results: Thirty-one patients were assessable for response. One of the 31 patients (3.2%) showed complete response, while 7 patients (22.6%) showed partial response; the objective response rate was 25.8%. Stable and progressive disease was observed in 6 (19.4%) and 17 patients (54.8%), respectively. The median time to progression was 4 months (95% CI 2.15–5.85). The median survival time of all patients was 9.5 months (95% CI 7.86–11.14). Conclusion: Gemcitabine and cisplatin combination therapy is moderately active and safe in patients with MBC previously treated with anthracycline and taxanes.

A phase II study of gemcitabine in combination with oxaliplatin as first-line chemotherapy in patients with inoperable biliary tract cancer

The aim of this study is to investigate the efficacy and safety of gemcitabine and oxaliplatin combination chemotherapy as first-line therapy in patients with inoperable biliary tract cancer (BTC). The treatment of this non-randomized phase II study consisted of gemcitabine 1,000 mg/m(2) intravenously (i.v.) on day 1 and oxaliplatin 85 mg/m(2) i.v. on day 2 every 2 weeks until disease progression, unaccep toxicity or patients' refusal. From Sept 2006 to Oct 2007, 40 patients were enrolled. In the ITT analysis, the objective response rate was 15.0% and the disease control rate was 52.5%. The median overall survival (95% CI) was 8.5 months (6.4-10.7) and the time to progression was 4.2 months (0.5-7.9). For the 305 cycles, observed grade 3/4 toxicity was uncommon. Gemcitabine and dose adjusted oxaliplatin combination chemotherapy had moderate anti-tumor activity and was well tolerated as a first-line treatment for patients with inoperable BTC.

Gemcitabine and oxaliplatin combination as first-line treatment for advanced pancreatic cancer: a multicenter phase II study

Gemcitabine is the only drug approved for single-agent therapy in advanced pancreatic carcinoma (APC). Gemcitabine-based combination chemotherapy has not yet shown promising results. This multicenter phase II study enrolled previously untreated patients with locally advanced and/or metastatic pancreatic adenocarcinoma. Patients received 1,000 mg/m(2) gemcitabine, 100-min infusion, day 1 and 100 mg/m(2) oxaliplatin, 2-h infusion, day 2; q2w. The primary end point was response rate (RR). Thirteen study centers enrolled 48 eligible patients of which 44 were evaluable. The RR, median overall survival, and median time to progression were 18.2%, 9.4 and 5.6 months, respectively. Sixteen patients (36.4%) experienced clinical benefit. The global quality of life scores improved by 11.71. Grade 3/4 peripheral sensory neuropathy was noted (2.1%), while the most common hematologic toxicity was anemia (grade 3/4, 6.3%). Gemcitabine and oxaliplatin combination chemotherapy showed a promising activity in APC patients and was well tolerated.

S-1 and Gemcitabine as an Outpatient-based Regimen in Patients with Advanced or Metastatic Pancreatic Cancer

The standard beneficial chemotherapy proved for patients with pancreatic cancer is a regimen containing gemcitabine. Novel oral fluoropyrimidine, S-1, can be added to gemcitabine to improve the efficacy of chemotherapy and to provide better convenience for patients. We aimed to evaluate the efficacy and safety of S-1 plus gemcitabine combination chemotherapy as a first-line treatment in patients with locally advanced or metastatic pancreatic cancer. Patients with histologically confirmed, bidimensionally measurable advanced/metastatic pancreatic cancer were eligible for the study. Chemotherapy consisted of S-1 (30 mg/m(2) p.o. bid from Day 1 to 14) and gemcitabine (1000 mg/m(2) on Days 8 and 15) every 3 weeks based on the results of a previously reported Phase I trial. Treatment was repeated until disease progression or unacceptable toxicity occurred. From January 2005 to August 2007, 22 patients were enrolled. Median age was 62 years (range, 50-73). Nineteen patients (86.3%) had metastases and of these, 11 patients (57.9%) had multiple liver metastases. The overall response rate was 27.3% (95% CI, 8.7-45.9), with a partial response in six patients, stable disease in nine (40.9%) and progressive disease in seven (31.8%). With a median follow-up of 25.4 months, the median time to progression and overall survival were 4.6 (95% CI, 2-7.2 months) and 8.5 months (95% CI, 6.8-10.1 months), respectively, and 1-year survival rate was 27.3%. S-1 plus gemcitabine was well tolerated. Grade 3/4 hematological adverse events were neutropenia (9.1/9.1%) and anemia (4.5/0%). Non-hematological adverse events were mainly gastrointestinal events. Twenty patients (91%) received chemotherapy on an outpatient basis. Combination chemotherapy of S-1 plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.

Irinotecan drug eluting beads used as a treatment of advanced intra hepatic cholangiocarcinoma

This report describes a 74-year-old male with unresectable intrahepatic cholangiocarcinoma (ICC). However surgical procedure is the only curative treatment, it often seems to be ineffective because of the aggressive behaviour of the disease. The role of systemic chemotherapy in the ICC is undefined with a median survival between 6.43 to 12.17 months obtained by using the combination chemotherapy of gemcitabine with cisplatin. In the present case, we performed a targeted treatment using drug eluting beads (DEB) with irinotecan (IRI) administered as transarterial-chemoembolization (TACE). After one session, the tumour vascularity decreased significantly at the one month evaluation on computed tomography (CT) scan of the liver. This case report suggested that minimally invasive transcatheter DEB embolization could be a promising, safe and effective treatment for selective patients with unresectable ICC.

Tegafur-Uracil Plus Gemcitabine Combination Chemotherapy in Patients with Advanced Non-small Cell Lung Cancer Previously Treated with Platinum

An open-label, single-arm prospective study was conducted to evaluate the efficacy and toxicity of the combination of gemcitabine and tegafur-uracil (UFT) in patients with advanced nonsmall-cell lung cancer (NSCLC) after the failure of previous platinum-containing regimens. Patients with advanced NSCLC received 200 mg/m2 of UFT twice daily from day 1 through 14 plus 900 mg/m2 of gemcitabine per day via intravenous injection on days 8 and 15. This regimen was repeated every 3 or 4 weeks. A total of 40 patients were enrolled. Eleven patients (28%; 95% confidence interval [CI], 15-44%) achieved a partial response. The median progression-free survival, median overall survival, and 1-year survival rate were 4.0 months (95% CI, 3.3-6.7 months), 12.6 months (95% CI, 7.0-22.3 months), and 51% (95% CI, 33-66%), respectively. The most common grade 3 or 4 toxicity was neutropenia (38%; 95% CI, 23-54%) and the rate of grade 3 or 4 nonhematologic toxicity remained at less than 5%. A multivariate Cox model showed that adenocarcinoma, nonsmoking history, and good performance status predicted better survival. Combination chemotherapy with UFT and gemcitabine showed a promising effectiveness and acceptable toxicity for patients with platinum-resistant NSCLC.

Phase II trial of weekly docetaxel and gemcitabine for previously untreated, advanced non-small cell lung cancer

Docetaxel and gemcitabine combination chemotherapy has been reported to be active against non-small cell lung cancer (NSCLC) and myelosuppression is the most common dose-limiting toxicity. This prospective phase II study was designed to test the hypothesis that better tolerance and increased dose intensity might be achieved if patients are treated with weekly administration schedule. Thirty-five patients with stage IIIB/IV NSCLC and a performance status 0-2 received first-line chemotherapy with docetaxel 35mg/m2 and gemcitabine 600mg/m2 on days 1, 8 and 15. Treatment was repeated every 4 weeks, for up to 4 cycles. In total, 85 chemotherapy cycles were given (median, 2; range, 1-4). Other than the completion of all 4 planned cycles (n=6), the main reasons for treatment discontinuation were toxicity (n=15) and progressive disease (n=14). The most frequently encountered toxic effects were anemia (52% of patients), nausea and vomiting (60%), fatigue (71%) and anorexia (57%). One patient died of bilateral pneumonitis, which developed shortly after the administration of second cycle. Disease control (objective response and stable disease) in the intent-to-treat (ITT) population was achieved in 60% of patients and the overall response rate was 29% (95% CI, 14-44%). With a median follow-up duration of 13 months, the median progression-free survival and overall survival were 2.8 (95% CI, 0.7-4.8) months and 10.6 (95% CI, 7.0-14.3) months, respectively. In conclusion, weekly schedule of docetaxel and gemcitabine has modest activity with acceptable toxicity profile in advanced NSCLC, but as high frequency of early discontinuation occurred does not merit further study with the present regimen.

A phase II study of capecitabine plus gemcitabine in patients with locally advanced or metastatic pancreatic cancer

This open-label, multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus gemcitabine combination chemotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer. We enrolled 63 patients who received capecitabine 830 mg/m(2) orally twice daily on days 1-21 plus gemcitabine 1000 mg/m(2) as a 30-min infusion on days 1, 8 and 15 every 4 weeks for up to six cycles. A total of 14 patients had partial responses giving an overall response rate of 22% (95% confidence interval [CI] 13-34%) in the intent-to-treat population. The median time to progression and overall survival were 3.9 months (95% CI 3.5-5.7) and 7.5 months (95% CI 5.0-10.0), respectively, and 1-year survival rate was 27.1% in the intent-to-treat population. Capecitabine plus gemcitabine was well tolerated. Grade 3 hematological adverse events were neutropenia (21%) and thrombocytopenia (2%); the only grade 4 hematological events were anemia (2%) and neutropenia (6%). Non-hematological adverse events were mainly gastrointestinal events and hand-foot syndrome, which affected 16% of patients. Grade 3/4 non-hematological events were infrequent. The combination of capecitabine plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.

Gemcitabine and Vinorelbine Combination Chemotherapy in Anthracycline- and Taxane-pretreated Advanced Breast Cancer

Anthracycline and taxanes are effective agents in advanced breast cancer and prolong survival times. Some patients achieve prolongation of life with capecitabine, gemcitabine, or vinorelbine, even after failure of both anthracycline and taxanes. We analyzed the efficacy and toxicity of gemcitabine and vinorelbine combination chemotherapy in anthracycline- and taxane-pretreated advanced breast cancer. The medical records of anthracycline- and taxane-pretreated metastatic breast cancer patients who received gemcitabine and vinorelbine combination chemotherapy at the Seoul National University Hospital were reviewed. Gemcitabine (1,000 mg/m(2)) and vinorelbine (25 mg/m(2)) were administered intravenously on days 1 and 8 every 3 weeks. Between 2000 and 2006, 57 patients were eligible (median age, 45 years), and the median number of previous chemotherapy regimens was 3 (range, 1 approximately 5). The overall response rate was 30% (95% CI, 18.1 approximately 41.9), and the disease control rate was 46% (PR, 30%; SD, 16%). The median duration of follow-up was 33.4 months, the median time-to-progression (TTP) was 3.9 months, and the median overall survival was 10.8 months. None of the patients with patients with anthracycline and taxane primary resistance showed a response and the median TTP for these patients was significantly shorter than that of other patients (1.9 vs. 4.4 months; p=0.018). Although the efficacy was unsatisfactory in patients with both anthracycline and taxane primary resistance, gemcitabine and vinorelbine combination chemotherapy showed comparable efficacy in anthracycline- and/or taxane-sensitive patients and the patients with secondary resistance, even after failure of second-line therapy. Grade 3/4 hematologic toxicities included neutropenia (18.1%) and febrile neutropenia (0.3%), and non-hematologic toxicities were tolerable. Gemcitabine and vinorelbine combination chemotherapy in anthracycline- and taxane-pretreated advanced breast cancer was effective and tolerable.

Gemcitabine plus UFT combination chemotherapy as second- or third-line therapy in non-small cell lung cancer: a pilot study

Gemcitabine plus UFT combination chemotherapy are highly effective and less toxic in the first line setting in patients with non-small cell lung cancer (NSCLC). The purpose of the study is to confirm the feasibility of this regimen as second- or third-line therapy in NSCLC. Fifteen patients with performance status of 0-1 were enrolled. UFT (tegafur 250 mg/m(2)/day) was administered orally twice a day from days 1-14, and gemcitabine of 900 mg/m(2) was administered intravenously on days 8 and 15 every three weeks on an outpatient setting. The treatment was repeated for at least 3 cycles and continued unless the disease progressed. The response rate and the disease control rate were 6.7% and 66.7%, respectively. Grade 3-4 toxicities included neutropenia in one patient and elevation of transaminases in one patient. The mean relative dose intensity of gemcitabine and UFT were 0.93 and 0.97, respectively. High disease control rate and less toxicity suggested the potential of gemcitabine and UFT combination chemotherapy as second- or third-line therapy in NSCLC.

Gemcitabine and Carboplatin Combination Chemotherapy for Elderly Patients with Advanced Non-small Cell Lung Cancer: A Feasibility Study

Although platinum based chemotherapy is known to improve the survival duration for the patients with non-small cell lung cancer, the role of platinum for elderly patient is not yet clear. We administered gemcitabine and carboplatin combination therapy to elderly patients with NSCLC. The aim of this study was to evaluate the efficacy and toxicities of this regimen for elderly patients. THE ELIGIBILITY CRITERIA WERE AS FOLLOWS: pathologically confirmed NSCLC, an age >or=65 years, advanced disease with stage IIIB or IV and the patients were chemotherapy-naive. The treatment regimen was as follows; gemcitabine 1,000 mg/m(2) was administered on days 1 and 8 and carboplatin AUC=5 was administered on day 1. This regimen was repeated every 3 weeks. The efficacy was evaluated in terms of the response rate, the time to progression and the overall survival duration. From Dec 2001 to Feb 2005, a total of 20 patients were entered into this study. The median patient age was 68 years (range: 65 approximately 75). 19 patients were evaluable for their treatment response. A partial response was obtained in 8 patients (response rate: 42.1%, 95% CI: 19.4 approximately 64.8%). The median time to progression and the survival duration were 136 days and 453 days, respectively. Among a total of 65 cycles of treatment, grade 3 or 4 leukopenia and thrombocytopenia were observed in 7.7% and 13.9% of the cycles, respectively. Grade 3 or 4 vomiting was observed in 7.7% of the cycles. Grade 3 skin rash developed in 1.5% of the cycles. 1 patient died of septic shock after chemotherapy. Gemcitabine and carboplatin combination chemotherapy was relatively safe and effective for treating elderly patients with NSCLC.