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Query: UMLS:C0027497 (nausea)
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Chemotherapeutic regimens containing cisplatin are the most effective ones in the treatment of squamous cell carcinoma of the head and neck. Because of the high rate of dose-limiting side effects of cisplatin, carboplatin, a second-generation cisplatin analogue, was tested in a phase II trial with fluorouracil in 55 previously untreated patients with advanced carcinoma of the head and neck. Among the 52 patients who completed the study, there were 17 complete responses (33%), 28 partial responses (54%), five patients with no change (10%), and two with progressive disease (4%). Toxic side effects of all courses summed together included leukopenia in 65% of courses, thrombocytopenia in 45% of courses, nausea or vomiting in 29% of courses, and change in serum creatinine level in 3% of courses. These data were compared with the results of our study with cisplatin and fluorouracil in comparable patients and indicated that carboplatin and fluorouracil is better for induction chemotherapy in the treatment of head and neck cancer than cisplatin and fluorouracil due to similar effectiveness but less toxic effect.
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PMID:Carboplatin. The better platinum in head and neck cancer? 265 67

A cooperative phase II study of cisplatin in head and neck cancer was conducted in 23 institutions. Eighty-nine patients were entered into this trial, of which 73 were evaluable. Two different regimens were employed in this study. Regimen A: cisplatin 10 mg/m2 intravenous (i.v.) infusion daily, days 1-5, q 3 wk. Regimen B: cisplatin 50 mg/m2 i.v. infusion, day 1, q 3 wk. Two patients achieved complete response and 17 achieved partial response with an overall response rate of 26.0%. By histological types, the response rate was 26.3% in the case of squamous cell carcinoma. Partial response were observed in 2 cases of adenocarcinoma and in one case each of adenoid cystic carcinoma and transitional cell carcinoma. The response rate was 19.4% for previously treated patients, as compared to 63.6% for the previously untreated group. Toxic effects were observed in 94.7% of 76 evaluable cases. From 50 to 68% of patients experienced nausea, vomiting and anorexia. No patient exhibited a serum creatinine level exceeding 2 mg/dl. Anemia and leukopenia were observed in 58.9% and 32.9% respectively. It is therefore concluded that cisplatin is markedly useful for the treatment of head and neck cancer.
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PMID:[A cooperative phase II study of cisplatin in patients with head and neck cancer]. 300 63

Combination chemotherapy with CDDP and 5-FU was performed in 19 patients with evaluable head and neck cancer and 2 CR patients and 7 PR patients were obtained; thus the response rate was 47.4%. Histologically, the present therapy is considered to be especially effective against well differentiated squamous cell carcinoma (83.3%). The present therapy is considered to be useful as a neo-adjuvant chemotherapy (75.0%), but it is desirable to perform at least 2 courses of treatment. The side effects observed were nausea, vomiting, anemia, leukocytopenia and alopecia, etc., and most of them were reversible. However, there were 2 patients in which the continuation of chemotherapy was impossible due to renal disorders.
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PMID:Combination chemotherapy with CDDP and 5-FU in head and neck cancer. 302 Oct 95

Twenty-seven patients with assessable, regionally advanced, or metastatic upper aerodigestive cancer of diverse histology received a combination of mitomycin C, adriamycin, and cis-diamminedichloroplatinum. All patients had previously received extensive surgery and/or radiation therapy. We observed an overall 46% partial response rate (12/26). This included seven of 15 (47%) responders with squamous cell carcinoma. Six of those seven patients responded within the initial month of treatment. For all study participants, the median time to progression and survival was 3.8 months and 7.3 months, respectively. Moderate-to-severe nausea, vomiting, anorexia, and alopecia were the most common toxicities. Myelosuppression (WBC less than 4,100 cells/mm3) and thrombocytopenia (PLTS less than 130,000 cells/mm3) occurred in 100% and 71% of the 21 patients with nadir data recorded, respectively. There were no episodes of sepsis nor did we detect any meaningful impairment in renal function. This regimen is active in the previously treated head and neck cancer patient and can be conveniently administered on an outpatient basis with acceptable and manageable side effects.
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PMID:A phase II clinical trial of the combination mitomycin C, adriamycin, and cis-diamminedichloroplatinum in patients with advanced upper aerodigestive cancer. 309 35

Because of the clinical activity of carboplatin in several types of tumors, this drug was studied in a phase II trial of 25 patients with advanced head and neck cancer [stage IV (M0)] without prior treatment. Six patients (24%) achieved objective response, including two patients with complete response. Carboplatin toxicity was mild in most patients, with nausea, vomiting, and myelosuppression being the most frequent side effects. No renal or neurologic toxicity was observed. Further trials of carboplatin in advanced head and neck cancer are warranted.
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PMID:Carboplatin, an active drug in advanced head and neck cancer. 353 Apr 43

The efficacy of two chemotherapy regimens for recurrent and inoperable squamous cell carcinoma of the head and neck is reported. All patients had failed prior surgery and/or radiotherapy. 23 patients (group A) were treated with Cisplatin 120 mg/m2 and Adriamycin 60 mg/m2. 21/23 were evaluable for tumour response. The overall response rate (RR) was 28.5% (6/21, 2 CR and 4 PR). Methotrexate 250 mg/m2 with Leucovorin-Rescue 5 X 10 mg/m2 and 5-Fluorouracil 600 mg/m2 were administered to 28 patients. In 26 evaluable patients a RR of 38.4% (10/26, 5 CR and 5 PR) was achieved. The responders in groups A and B had a median survival of 98 and 85.5 weeks respectively and the non-responders 27 weeks in both groups. Nausea, vomiting and alopecia were common and severe in the DDP/ADM group. The major toxic effect of MTX/5-FU was neutropenia with two associated deaths from septicemia, although subjective side-effects were almost completely absent. MTX/5-FU can be recommended for the palliative treatment of recurrent squamous head and neck cancer because of an acceptable response rate, good subjective tolerance and the possibility of outpatient treatment.
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PMID:[Chemotherapy of recurrent squamous cell carcinomas in the ENT area with cisplatin/adriamycin (DDP/ADM) and methotrexate/5-fluorouracil (MTX/5-Flu): a retrospective comparison of 2 protocols]. 374 8

Methylglyoxal bis (guanylhydrazone) (MGBG) is an inhibitor of polyamine synthesis. In vitro studies demonstrate the accumulation of some tumor cells in S and G2 phases of the cell cycle. Nineteen patients with advanced head and neck cancer were entered in a Phase II trial of MGBG. MGBG, 500 mg/M2, was administered as a brief intravenous infusion weekly for 4 weeks, then every 2 weeks. Dose modifications were based on cumulative toxicity after 2 weekly treatments. All but three patients had prior exposure to chemotherapy for disease recurrence. Of 17 patients evaluable for response and toxicity, one brief partial response was observed. The most common toxicities were mild to moderate nausea, vomiting, diarrhea, and stomatitis. Myelosuppression occurred in three patients. Dose modifications were required in four patients; a maximum dose of 700 mg/M2 was tolerated. The results of four other Phase II single and combination chemotherapy trials of MGBG in head and neck cancer are reviewed. The single agent response rate in 59 patients was 22% (range, 6%-41%). The poor response rate observed in this trial was similar to that in other trials in which a heavily pretreated group of patients was evaluated. It is concluded that single agent MGBG is not a useful drug in heavily pretreated recurrent disease patients. However, because of its biochemical effects, further testing in combination with cycle specific agents and in larger numbers of patients with minimal prior treatment may be warranted.
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PMID:Phase II trial of methylglyoxal bis (guanylhydrazone) (MGBG) in advanced head and neck cancer. 377 8

A Phase II study of UFT for head and neck cancer was conducted in 10 institutions. UFT is a mixture of Futraful and uracil. Eighty-four patients entered this trial, of which 60 were evaluable. UFT was administered orally at a daily dose of 600 mg/day. Eight patients achieved complete response and 10 achieved partial response with an over-all response rate of 30.0 %. Evaluating response according to by histology, the response rate was 30.9% for cases of squamous cell carcinoma. Complete response was observed in one case of undifferentiated carcinoma. Response rate according to primary site was 33 to 40% for the nose & paranasal sinuses, mesopharynx, hypopharynx and larynx. The response rate was 28.9% for the group of patients treated previously, and 33.3% for the group previously untreated. The mean time for 50% or more regression of the tumor was 4.3 weeks. Toxic effects appeared in 40.3% of 67 evaluable cases as anorexia, nausea, vomiting, stomatitis, diarrhea etc. In one case of maxillary carcinoma, severe bone marrow suppression was observed. We concluded that UFT therapy was markedly effective for head and neck cancer.
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PMID:[Phase II study of UFT for head and neck cancer]. 392 39

A new anticancer agent, UFT which is a mixture of 1-(2-tetrahydrofuryl)-5-fluorouracil and uracil in a molar ratio of 1:4 was administered orally at a dose of 600 mg/day every day. Forty-three patients were evaluable. Eight patients achieved a complete response and eight achieved a partial response with an overall response rate of 37.2%. In terms of response by histology, a response rate was 32.4% (11/34) in cases of squamous cell carcinoma and 75% (3/4) in cases of adenocarcinoma. A response rate by primary site was 57.1% in the nose and paranasal sinuses, 50.0% in the oropharynx and 30.0% in the oral cavity. A response rate was 36.1% in patients with prior treatment and 42.9% in patients with no prior treatment, but there was no statistical significance. Eight of 43 patients developed toxic effects. Most of them were mild such as anorexia, nausea, and stomatitis, but in one case of maxillary sinus carcinoma, severe bone marrow suppression was observed. UFT is a considerably effective and useful drug in the treatment of head and neck cancer. It is possible to increase cure rate by examining various usages of UFT.
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PMID:Clinical trials on UFT in the treatment of head and neck cancer. 393 86

In seven patients with head and neck cancer, two-route-infusion chemotherapy using cisplatin (CDDP) and sodium thiosulfate (STS) was performed and their pharmacokinetics were studied. As for the time of administration of STS, the treatment courses were classified into 4 groups: STS was given 10 minutes after the administration of CDDP in group I, 30 minutes in group II, 60 minutes in group III and the same schedule as group II in addition to prior loading of STS in group IV. The peak level of plasma CDDP was 1.27-3.33 micrograms/ml and the half-lives of the alpha-phase in groups I, II, III and IV were 58, 97, 126 and 44 minutes, respectively. The peak level of plasma non-protein-bound CDDP was 1.00 +/- 0.45 micrograms/ml and the half-life was 53 minutes. The peak level of plasma STS was 32.2 and 33.3 mg/dl and the half-life was 95 minutes. No serious side effect was observed but slight nausea and anorexia occurred in two courses. This study suggests that the liberation of CDDP from protein-bound CDDP was achieved by administration of STS and that the urinary excretion of CDDP from the plasma was also increased immediately after the administration of STS. The mechanism of relief of CDDP side effects by STS is supposed to involve both a neutralizing action CDDP and reversal of CDDP-induced, cross-linked DNA.
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PMID:[Pharmacokinetic study of cisplatin and sodium thiosulfate in two-route-infusion chemotherapy]. 396 47


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