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 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

This phase II study of gemcitabine and epirubicin evaluated the activity and toxicity in advanced breast cancer. Female patients with stage IIIB or IV breast cancer received gemcitabine 1000 mg/m2 and then epirubicin 15 mg/m2 on days 1, 8, and 15 of 28-day cycles. Thirty-five patients with stage IV disease, a median age of 59 years (range, 39-73), and a median Karnofsky performance status of 90 (range, 60-100) were enrolled. Fourteen (40.0%) patients received prior chemotherapy (12 adjuvant, 4 metastatic, 2 both). Of 35 evaluable patients, 10 had PR, for an overall RR of 28.6%, and 12 (34.3%) patients had SD. Median time to progression and overall survival were 5.8 months (95% CI, 3.4-9.5 months) and 17.1 months (95% CI, 11.2-19.9 months), respectively. WHO grade 3/4 neutropenia occurred in 51.5% of patients without febrile neutropenia, and grade 3 thrombocytopenia in 29.4% of patients without hemorrhage or platelet transfusions. The most common nonhematologic toxicities were grade 3 alopecia (38.2%) and nausea/vomiting (11.4%). There were no grade 4 nonhematologic toxicities. Gemcitabine plus epirubicin is active and well tolerated in patients with metastatic breast cancer. Future studies should continue to evaluate the impact of various schedules on outcome.
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PMID:Gemcitabine combined with epirubicin in the treatment of patients with locally advanced or metastatic breast cancer: a phase II study. 1528 40

A phase I study was conducted to determine the recommended phase II dose, safety profile and anti-tumor activity of a combination regimen of gemcitabine, doxorubicin and cisplatin (GAP). Gemcitabine (G) and doxorubicin (A) were administered on days 1 and 8 at increasing doses (starting level 800 and 15 mg/m, respectively). Cisplatin (P) was given at a fixed dose of 50 mg/m2 (day 1). Treatment cycles were repeated every 3 weeks. Nineteen patients received 76 cycles of treatment. A and G were escalated up to 20 and 1000 mg/m2, and finally de-escalated to 15 and 800 mg/m2. The dose-limiting toxicity was neutropenic fever that was observed in 21% of the patients. Non-hematological toxicities included mild/moderate nausea, vomiting, diarrhea and fatigue, observed in 58, 37, 21 and 95% of the patients, respectively. Of 19 patients with evaluable disease, six patients had a partial response yielding an overall response rate of 31.6 % (95% confidence interval 12.6-56.6%) by intention-to-treat. We conclude that GAP is an active and tolerable treatment combination, with minimal visceral organ toxicities.
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PMID:Phase I trial of gemcitabine, doxorubicin and cisplatin (GAP) in patients with advanced solid tumors. 1631 94

Gemcitabine and oxaliplatin have shown single-agent activity in relapsed ovarian cancer. This combination was used to determine response rates, time-to-event efficacy measures, and toxicity in patients with recurrent ovarian cancer. Patients with prior platinum-based chemotherapy who had measurable lesions and/or elevated CA-125 levels were identified as group A (platinum-refractory/platinum-resistant patients) and group B (platinum-sensitive patients). All patients received gemcitabine 1000 mg/m(2) on days 1 and 8 and oxaliplatin 130 mg/m(2) on day 8 every 21 days for up to eight cycles. Seventy-five patients (21 in group A and 54 in group B), with a median age of 58 years (range, 37-78), were enrolled. A median of six cycles (range, 1-8) was administered. By intent-to-treat analysis, 15 patients with measurable disease achieved partial response for an overall best response rate of 20.0% (9.5% in group A and 24.1% in group B). CA-125 response was observed in 48.4% patients (30.0% in group A and 57.1% in group B). Median time to progressive disease was 7.1 months (95% CI, 5.6-9.0 months) with 5.0 months in group A and 8.3 months in group B. Median overall survival was 17.8 months (95% CI, 12.9-21.3 months) with 9.2 months for group A and 20.0 months for group B. Major grade 3/4 toxicities were neutropenia (61.3%), leukopenia (24.0%), nausea (16.0%), and vomiting (22.7%). We conclude that the combination of oxaliplatin and gemcitabine is active in patients with recurrent ovarian cancer, but the regimen is unsatisfactory for further study due to modest response and relatively high toxicity.
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PMID:Phase II study of gemcitabine and oxaliplatin in patients with recurrent ovarian cancer: an Australian and New Zealand Gynaecological Oncology Group study. 1736 13

Gemcitabine is the only cytotoxic agent approved by FDA for the treatment of pancreatic carcinoma. Gemcitabine has a relatively safe profile. Major side effects include bone marrow suppression and flu-like syndrome. Transient abnormalities of liver transaminase enzymes are seen in two third of patients: elevations of alkaline phosphatase and bilirubin are less common, but severe hepatic toxicity is uncommon. Four case reports regarding severe hepatic toxicity of gemcitabine leading to rapid deterioration in patients' health status and death have been reported. We report the fifth case in which liver functions were within normal limits but liver toxicity was preceded by radiological findings on the MRI. We describe a 61-year-old male with stage T4N1M0 who initially received gemcitabine-oxaliplatin (GemOx) regimen was switched to gemcitabine-capecitabine (every two weeks schedule) after four months of therapy due to lack of response. Restaging CT scan after eight-weeks showed new multiple foci of low attenuation resembling simple cysts. MRI of the abdomen was performed which revealed early and active fibrosis. Hepatitis panel were negative. Subsequently the patient developed nausea, vomiting, abdominal pain and weight loss and was referred for palliative radiotherapy. Gemcitabine was discontinued and follow-up CT scan two months later showed stable lesions in the liver. In conclusions, four cases of gemcitabine-induced liver toxicity has been reported in the literature. Such toxicity is manifested by elevated liver transaminases and more common in the presence of liver metastasis. However, our case showed that gemcitabine-induced liver toxicity can be detected by MRI, before liver enzymes start to rise and discontinuation of gemcitabine can prevent further liver toxicity and fibrosis. Report of such cases is encouraged as it will bring awareness among clinicians caring for such patients receiving gemcitabine.
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PMID:Gemcitabine-induced liver fibrosis in a patient with pancreatic cancer. 1762 1

Gemcitabine is a commonly used chemotherapeutic agent for a variety of tumor types. Although this nucleoside analogue antineoplastic agent is similar in structure to cytarabine, central nervous system toxicities have rarely been attributed to gemcitabine. Reversible posterior leukoencephalopathy syndrome (RPLS) is a rare but increasingly identifiable clinicoradiologic process in cancer patients associated with cytotoxic and immunosuppressive agents. The syndrome is characterized by acute to subacute onset of headache, nausea, vomiting, altered mental status, seizures, stupor, and visual disturbances. The pathophysiology of RPLS continues to remain controversial but likely involves loss of cerebrovascular autoregulation leading to arteriole leakage. Radiologically, posterior occipital white matter edema is noted, with characteristic findings on magnetic resonance imaging. Often the syndrome is reversible with treatment of concurrent hypertension or removal of the causative agent; however, failure to quickly recognize the syndrome and discontinue the offending agent may result in profound and permanent central nervous system dysfunction or death. This article describes a case of RPLS attributed to gemcitabine use for pancreatic cancer. Such a descriptive case serves as a platform for the discussion of the syndrome, proposed mechanisms of central nervous system damage, and review of the currently available literature on the topic. With increased awareness of RPLS by oncologists and other medical providers, cancer patient care may be improved and further insight into this complication of therapy through continued research may be gained.
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PMID:Gemcitabine-induced reversible posterior leukoencephalopathy syndrome: a case report and review of the literature. 1805 53

Twenty-three patients with muscle-invasive bladder cancer were treated with combination chemotherapy of gemcitabine and carboplatin. Gemcitabine at a dose of 800 mg/m2 by intravenous infusion for 30 minutes on Days 1, 8 and 15. Carboplatin at an AUC of 4, according to the Calvert formula, was administered by intravenous infusion for 3 hours on Day 2. The treatment was repeated every 21 days without drug-free-weeks for a total of 2 cycles. Six patients achieved a complete response(CR)and 8 patients achieved a partial response(PR). Overall response rate(CR+PR) was 60.8%. In addition, 7 patients achieved stable disease(SD), whereas 2 were found to have progressive disease (PD). Although Grade 3 or 4 leukocytopenia was seen in 10 patients(43.4%), low-grade toxicities of anemia, thrombocytopenia and nausea were seen in several patients, so it was possible to complete the treatment on schedule in all patients. Five SD patients died(4 by cancer and 1 by another cause), 2 PD patients were found to have disease progression, and 16 patients were alive without recurrence with a mean follow-up period of 12.6 months(range: 8-19).
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PMID:[Short-term outcome of neoadjuvant gemcitabine-carboplatin therapy for muscle-invasive bladder cancer]. 1819 33

Advanced ovarian carcinoma in early progression (<6 months) (AOCEP) is considered resistant to most cytotoxic drugs. Gemcitabine (GE) and oxaliplatin (OXA) have shown single-agent activity in relapsed ovarian cancer. Their combination was tested in patients with AOCEP in phase II study. Fifty patients pre-treated with platinum-taxane received q3w administration of OXA (100 mg m(-2), d1) and GE (1000 mg m(-2), d1, d8, 100-min infusion). Patient characteristics were a : median age 64 years (range 46-79),and 1 (84%) or 2 (16%) earlier lines of treatment. Haematological toxicity included grade 3-4 neutropaenia (33%), anaemia (8%), and thrombocytopaenia (19%). Febrile neutropaenia occurred in 3%. Non-haematological toxicity included grade 2-3 nausea or vomiting (34%), grade 3 fatigue (25%),and grade 2 alopecia (24%). Eighteen (37%) patients experienced response. Median progression-free (PF) and overall survivals (OS) were 4.6 and 11.4 months, respectively. The OXA-GE combination has high activity and acceptable toxicity in AOCEP patients. A comparison of the doublet OXA-GE with single-agent treatment is warranted.
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PMID:Gemcitabine-oxaliplatin combination for ovarian cancer resistant to taxane-platinum treatment: a phase II study from the GINECO group. 1919 Jun 32

Gemcitabine is widely used for the treatment of advanced biliary tract cancer (BTC) as first-line chemotherapy. However, there is no standard chemotherapy for patient with advanced BTC refractory to gemcitabine. We conducted a multicenter phase II study of S-1 monotherapy as second-line chemotherapy for patients with advanced BTC that were refractory to gemcitabine. S-1 was administered orally at a dose of 80 mg/m(2) for 28 days, followed by 14 days of rest. This regimen was repeated every 6 weeks. Tumor response was assessed every two cycles using the Response Evaluation Criteria in Solid Tumors version 1.0. Twenty-two patients were enrolled between March 2007 and January 2010, with 14 patients (64%) representing cases of recurrence after surgery. The overall response rate was 22.7%, and the overall disease control rate was 50.0%. The median overall survival time was 13.5 months (95% CI, 7.1-23.1 months) and the median time-to-progression was 5.4 months (95% CI, 2.6-17.2 months). Grade 3/4 toxicities included neutropenia (5%) and anemia (5%). The most common non-hematological toxicities were nausea (27%), anorexia (55%), and pigmentation (32%). In conclusion, S-1 monotherapy is feasible and moderately efficacious second-line chemotherapy for advanced BTC.
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PMID:Multicenter phase II study of S-1 monotherapy as second-line chemotherapy for advanced biliary tract cancer refractory to gemcitabine. 2092 41

Gemcitabine and oxaliplatin have been demonstrated to have synergistic activity in several human cancer cell lines and varying patterns of toxicity. Gemcitabine is a very well tolerated drug with mild myelosuppression, asthenia and nausea/vomiting as its main toxicities. On the other hand, cumulative peripheral neurotoxicity is the main side effect of oxaliplatin. Therefore, there is a strong preclinical rationale to combine gemcitabine and oxaliplatin (Gemox) and to test this regimen as an alternative approach to gemcitabine with cisplatin or carboplatin as a treatment for different tumors. By reviewing the literature we found that the Gemox regimen seems to be active in the treatment of various kinds of tumors and is well tolerated. Further studies, especially to determine the optimal schedule, are clearly warranted. In addition, we report here our single-institution experience with this combination as salvage treatment for heavily pretreated cancer patients.
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PMID:Gemox: a widely useful therapy against solid tumors-review and personal experience. 2112 51

Hepatic metastasis is a common cause of treatment failure after curative resection of pancreatic cancer. We report a pilot study of hepatic arterial infusion (HAI) chemotherapy with gemcitabine and 5-fluorouracil (5-FU) for postoperative liver metastases from pancreatic cancer. Five patients who had undergone curative resection of liver metastases from pancreatic cancer received HAI of gemcitabine and 5-FU between October 2008 and September 2010 at Kanazawa University Hospital. Gemcitabine at a dose of 800 mg was infused over 30 min via a bedside pump. After gemcitabine administration, 250 mg of 5-FU was infused continuously over 24 h on days 1-5, comprising one cycle of therapy. These treatment cycles were continued biweekly. In the evaluation according to RECIST criteria, a partial response was obtained in 2 of the 5 cases, with stable disease being achieved in the remaining 3 cases (response rate, 100%). In 4 of the 5 cases, a decrease in serum tumor marker CA19-9 was observed after 10 HAI treatment cycles. The median time to treatment failure was 10 months (range 3-17). As to adverse events, leukocytopenia was grade 3 in 1 of 4 affected cases and all 5 were anemic, although 4 of the 5 cases had anemia prior to HAI therapy. Grade 2 thrombocytopenia was observed in 2 cases. No nonhematologic events, such as nausea, diarrhea, liver injury and neuropathy, occurred. There were no life-threatening toxicities, but 4 cases (80%) developed catheter complications, and the HAI catheter and subcutaneous implantable port system had to be removed. HAI delivers high doses of chemotherapeutic agents directly into tumor vessels, producing increased regional levels with greater efficacy and a lower incidence/severity of systemic side effects. In conclusion, HAI chemotherapy is useful and safe for the treatment of malignancies confined to the liver.
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PMID:Pilot study of hepatic arterial infusion chemotherapy with gemcitabine and 5-fluorouracil for patients with postoperative liver metastases from pancreatic cancer. 2297 95


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