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  • TOXICITY  (4)
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  • 1
    Keywords: CANCER ; SURVIVAL ; tumor ; COMBINATION ; Germany ; PHASE-I ; THERAPY ; TOXICITY ; DEATH ; DISEASE ; RISK ; TUMORS ; TIME ; PATIENT ; RESPONSES ; 5-FLUOROURACIL ; ACID ; TRIAL ; PROGRESSION ; AGE ; chemotherapy ; doxorubicin ; SAFETY ; FLUOROURACIL ; CISPLATIN ; GASTRIC-CANCER ; BOLUS ; PHASE-II ; SINGLE ; ELDERLY-PATIENTS ; SODIUM ; gastric cancer ; INTERVAL ; PHASE ; TOLERABILITY ; PLUS ; EUROPEAN-ORGANIZATION ; NAUSEA ; COOPERATIVE GROUP ; EPIRUBICIN ; GASTROINTESTINAL CANCER ; HIGH-DOSE METHOTREXATE ; mitomycin C ; pegylated liposomal ; phase II ; SUPPORTIVE CARE ; LIPOSOMAL DOXORUBICIN
    Abstract: Mitomycin C (MMC) in combination with infusional 5-fluorouracil (5-FU) is a well-tolerated active combination therapy for advanced gastric cancer. Pegylated liposomal doxorubicin (Caelyx) has been combined with this regimen in a phase I study exhibiting promising activity in patients with upper gastrointestinal tumors. In the present study, we investigated activity and tolerability of this three-drug regimen in patients with gastric cancer. Patients with advanced or metastatic gastric cancer were recruited to receive weekly infusional 5-FU (2000 mg/m(2)) mixed with sodium folinic acid (FA; 500 mg/m(2)) in one pump (days 1, 8,15, 22, 29, 36). On days 1 and 29, Caelyx (20 mg/m(2)) was given as a 1-h, and MMC (7 mg/m(2)) was applied as bolus injection on days 8 and 36. Treatment courses were repeated on day 57. Twenty-seven patients with a median age of 66 years were recruited in a single center; 56% had histologically proven peritoneal carcinomatosis and 26 patients are evaluable for toxicity. Common Toxicity Criteria of the National Cancer Institute grade 3 toxicity was recorded in 34% of the patients (anemia 12%, leukocytopenia 8%, febrile neutropenia 4%, thrombocytopenia 12%, nausea 15%, diarrhea 8% and mucositis 4%). One patient developed hemolytic-uremic syndrome. One complete (5%) and eight partial responses (42%) were observed in 19 patients evaluable for response according to WHO criteria. Seven patients had no change (37%) and three (16%) progressive disease. Six patients with peritoneal carcinomatosis not amenable to WHO response assessment had progression-free intervals between 8 and 21 months. Median survival for all patients was 14.7 months and median time to progression was 8.4 months. We conclude that this new three-drug combination regimen yields a promising overall response rate (47%) in patients with gastric cancer despite the inclusion of a majority of elderly patients at moderate or high risk of death in this trial. Its safety and good tolerability as established in the phase I trial was confirmed. (c) 2005 Lippincott Williams M Wilkins
    Type of Publication: Journal article published
    PubMed ID: 15746580
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  • 2
    Keywords: CANCER ; CELLS ; IN-VITRO ; tumor ; TUMOR-CELLS ; AGENTS ; CELL ; human ; MODEL ; TOXICITY ; SYSTEM ; VOLUME ; DEATH ; CLONING ; DRUG ; TUMORS ; MICE ; COMPLEXES ; REDUCTION ; INDUCTION ; ANTITUMOR-ACTIVITY ; BREAST ; breast cancer ; BREAST-CANCER ; MOUSE ; NO ; CELL-DEATH ; MOUSE MODEL ; sensitivity ; CISPLATIN ; TUMOR CELLS ; ONCOLOGY ; RE ; TRANSITION ; development ; TUMOR-CELL ; cell death ; pharmacology ; USA ; anticancer drug ; antitumor activity ; FULVENES ; human tumor cloning assay ; HUMAN-BREAST ; hydridolithiation ; MCF-7 xenograft ; METALLOCENES ; ORGANIC-CHEMISTRY ; POTENTIAL ANTICANCER DRUGS ; SUBSTITUTED ANSA-TITANOCENE ; super hydride ; TITANIUM DICHLORIDE ; titanocene
    Abstract: Bis-[(p-methoxybenzyl)cyclopentadienyl] titanium dichloride, better known as Titanocene Y, is a newly synthesized transition metal-based anticancer drug. We studied the antitumor activity of Titanocene Y with concentrations of 2.1, 21 and 210 mu mol/l against a freshly explanted human breast cancer, using an in-vitro soft agar cloning system. The sensitivity against Titanocene Y was highly remarkable in the breast cancer tumor in the full concentration range. Titanocene Y showed cell death induction at 2.1 mu mol/l, well comparable to cisplatin, given at a concentration of 1.0 mu mol/l. A further preclinical development of Titanocene Y was warranted and therefore an MCF-7 human breast cancer xenograft nonobese diabetic/severe combined immunodeficient mouse model was used. Titanocene Y was given for 21 days at 30 mg/kg/ day (75% of the maximum tolerable dose of Titanocene Y), which resulted in the reduction of the tumor volume to around one-third, whereas no mouse was lost because of the surprisingly low toxicity of Titanocene Y
    Type of Publication: Journal article published
    PubMed ID: 17264764
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  • 3
    Keywords: CANCER ; tumor ; Germany ; LUNG ; THERAPY ; TOXICITY ; liver ; SURGERY ; PATIENT ; CYCLE ; BREAST ; breast cancer ; BREAST-CANCER ; TRIAL ; EFFICACY ; chemotherapy ; doxorubicin ; CYCLOPHOSPHAMIDE ; RANDOMIZED-TRIAL ; paclitaxel ; GUIDELINES ; PREOPERATIVE CHEMOTHERAPY ; GEMCITABINE ; PHASE ; TOLERABILITY ; PLUS ; EVENTS ; EPIRUBICIN ; darbepoietin ; docetaxel ; dose density ; NEOADJUVANT CHEMOTHERAPY ; pegfilgrastim ; phase I/II study ; pre-operative chemotherapy ; RECOMMENDATIONS
    Abstract: We recruited 50 patients with T2-4 NO-2 MO primary breast cancer into a phase I/II study to define the maximum tolerated dose (MTD), efficacy and tolerability of preoperative gemcitabine (11250 mg/m(2) fixed dose) plus epirubicin (doses escalated from go mg/m(2)) for 5 cycles followed by 4 cycles of docetaxel (scheduled fixed dose 100 mg/m(2) given on day 1 every 2 weeks (q2w) with pegfilgrastim support. The MTD for epirubicin was 100 mg/m(2), but the docetaxel dose had to be reduced to 80 mg/m(2). Dose-limiting toxicities included fatigue, stomatitis, diarrhea and dyspnea (all grade 3) during gemcitabine plus epirubicin, and fatigue (grade 3) and allergic reaction (grade 4) during docetaxel treatment, respectively. A pathologic complete response could be achieved in 13 patients (pTO + pTis, 26%), and in the breast and axilla in 12 patients [(pTO or pTis) + pNO, 24%). Breast-conserving surgery (BCS) was possible in 35 patients (70%). Main grade 3/4 adverse events at MTD were fatigue (57/0%), leukopenia (27/8%), and liver (14/0%) and lung toxicity (14/0%). In conclusion, gemcitabine plus epirubicin 1250/100 mg/m(2) q2w followed sequentially by docetaxel 80 mg/m(2) q2w is highly effective as pre-operative chemotherapy with manageable toxicity. However, response and BCS rates could not be increased by administering gemcitabine plus epirubicin and docetaxel in a dose-dense fashion
    Type of Publication: Journal article published
    PubMed ID: 16162980
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  • 4
    Keywords: CANCER ; SURVIVAL ; tumor ; carcinoma ; COMBINATION ; Germany ; LUNG ; THERAPY ; TOXICITY ; DISEASE ; liver ; POPULATION ; SITE ; SITES ; TIME ; PATIENT ; 5-FLUOROURACIL ; ACID ; TRIAL ; PROGRESSION ; AGE ; colorectal cancer ; COLORECTAL-CANCER ; EFFICACY ; metastases ; SAFETY ; OXALIPLATIN ; RANDOMIZED-TRIAL ; BOLUS ; REGIMENS ; PHASE-II ; ELDERLY-PATIENTS ; overall survival ; second-line treatment ; intensity ; PHASE ; PLUS ; REMISSION ; phase II ; 2 DIFFERENT SCHEDULES ; capecitabine ; CPT-11 ; FLUOROURACIL-LEUCOVORIN ; irinotecan ; PLUS IRINOTECAN ; salvage chemotherapy
    Abstract: The efficacy of combination therapy with irinotecan and capecitabine has been demonstrated for the first-line treatment of metastatic colorectal cancer (MCRC). The aim of this trial was to evaluate the efficacy and safety of this combination in MCRC as second-line treatment after failure of 24-h infusional 5-fluorouracil (5-FU24h) and folinic acid (FA). Patients pre-treated with 5-FU24h/FA were recruited at two institutions to receive 6 x weekly irinotecan 70 mg/m(2) and capecitabine (1000 mg/m(2) b.i.d. days 1-14 and 22-35). Courses were repeated on day 50. In elderly patients (〉65 years) a 20% dose reduction of both drugs was scheduled. Twenty-eight patients [M/F 20/8; median age 65 years (range 44-79); median ECOG score 1] were enrolled. The most frequent sites of metastases were liver, n = 20, lymph nodes and lungs, n=10, respectively. Half of the patients had two or more metastatic sites. A total of 71 treatment courses (median 2, range 1-8) were administered. Main toxicities [worst per patient (%); CTC grade 1/2/3/4] were: anaemias 18/14/-/-; leukocytopenia 11/21/-/-; thrombocytopenia diarrhea 18/36/21/-; nausea/vomiting 43/29/4/-; mucositis 4/11 /-/-; alopecia 7/25/-/-; hand-foot syndrome 7/21/-/-; fatigue 14/14/-/-; renal insufficiency (caused by diarrhea and exsiccosis) -/-/-/7. Dose intensity in the first course was [median/mean (%)]: irinotecan 92/83; capecitabine 88/82. Twenty-three patients are evaluable for response analysis (five did not complete the first course): three patients showed partial remissions (13%) and 11 patients had stable disease (48%). Median time to progression was 3.0 months for the total population (range 1.4-17.3) and 6.5 months for responders (partial response plus no change). Seventy-four percent of the patients received a third-line therapy. Overall survival was 15.7 months calculated from the start of study treatment. Second-line therapy with irinotecan and capecitabine yielded a tumor control in 61% of patients with MCRC. Efficacy and toxicity data are comparable to 5-FU/irinotecan combinations, although the likelihood of severe diarrhea appears to be higher with capecitabine/irinotecan. (C) 2005 Lippincott Williams Wilkins
    Type of Publication: Journal article published
    PubMed ID: 15613902
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