Phase II evaluation of diaziquone in recurrent head and neck cancer.
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Aged↗
Biomedical subjects
M Al-Sarraf
Publications and source records attributed to M Al-Sarraf.
A randomized trial of cisplatin (CACP) + 5-fluorouracil (5-FU) infusion and CACP + 5-FU bolus for recurrent and advanced squamous cell carcinoma of the head and neck.
One of the most active chemotherapeutic regimens for treatment of advanced and recurrent head and neck cancer is cisplatin (CACP) + 5-fluorouracil (5-FU) infusion with a response rate of 90% in advanced, previously untreated patients and 70% in patients with recurrent disease. Forty-four patients from two Wayne State University-affiliated hospitals were entered into a randomized trial of CACP (100 mg/m2) day 1 and 24-hour infusion of 5-FU (1000 mg/m2) days 1 through 4 versus CACP (100 mg/m2) day 1 and bolus 5-FU (600 mg/m2) day 1 and day 8. Thirty-eight patients were evaluable for three induction courses. Response for the infusion arm was 72% (4/18 complete response [CR] + 9/18 partial response [PR]). Response for the bolus arm was 20% (2/20 CR + 2/20 PR). The difference in response was statistically significant by chi-square analysis (P less than 0.01). Seventy percent of the patients on the bolus arm experienced leukopenia with several episodes of grades 3 and 4 leukopenia. In addition, 50% of the patients on the bolus arm experienced thrombocytopenia. Stomatitis was more frequent on the infusion arm but it was mild and reversible. The complete responders on either arm have a median survival of 120+ weeks; partial responders, 30 weeks. Cisplatin + 5-FU infusion produces a superior response as initial chemotherapy for three courses compared with CACP and 5-FU bolus.
Antineoplastic Combined Chemotherapy Protocols↗
Improved complete response rate and survival in advanced head and neck cancer after three-course induction therapy with 120-hour 5-FU infusion and cisplatin.
In a series of three consecutive pilot studies carried out between 1977 and 1981 at Wayne State University, Detroit, Michigan, designed to test the feasibility of multimodality therapy in patients with previously untreated advanced squamous cell carcinoma of the head and neck, patients received three different induction chemotherapy regimens: cisplatin + Oncovin (vincristine) + bleomycin (COB) for two courses; 96-hour 5-fluorouracil (5-FU) infusion and cisplatin for two courses, or 120-hour 5-FU infusion + cisplatin for three courses. Over-all response rates (complete response + partial response) to each of the three induction chemotherapy regimens were high: 80%, 88%, and 93%, respectively. Superior complete response rate in the group receiving three courses of 120-hour 5-FU infusion + cisplatin was 54% versus 29% for COB and 19% for two-course 96-hour 5-FU infusion + cisplatin (P = 0.04). Significant survival advantage at 18 months minimum follow-up for the group receiving three courses of 120-hour 5-FU + cisplatin induction therapy was found. Actual T and N stage may influence the clinical complete response rate. Responders to initial chemotherapy have significantly better survival as compared to nonresponders regardless of subsequent surgery and/or radiotherapy. These studies show that a multimodality approach to management of advanced head and neck cancer is feasible. Superior complete response rate and survival in one of the treatment groups suggest that choice of induction chemotherapy regimens and/or number of courses is of prime importance in such multimodality treatment programs.
Adolescent↗
Evaluation of cyclophosphamide, adriamycin, and cis-platinum (CAP) in patients with disseminated prostatic carcinoma. A phase II study.
A prospective study was conducted to evaluate response rate and toxicity of the combination of cyclophosphamide, adriamycin, and cis-platinum in patients with disseminated hormonally resistant prostatic carcinoma. Twenty-two patients were entered in the study: 19 were evaluable for response. One patient achieved partial remission while 14 (73%) had stable disease. Four patients had progressive disease. Patients with stable disease and partial remission had subjective improvement and survived significantly (p less than 0.03) longer than patients with progressive disease (58 weeks vs. 22 weeks). Toxicity was mainly hematological, and one patient died from sepsis secondary to leukopenia. Nausea and vomiting was moderate to severe, with one patient refusing cis-platinum for that reason. Renal toxicity was tolerable and reversible. Lack of good measurable disease makes generalization difficult, but pointers from animal models, along with the biological activity suggested by our results, make this a worthwhile combination to be considered for a trial in a larger population with measurable disease or in a randomized trial vs. the more effective single agent.
Acid Phosphatase↗
Ototoxicity from cis-platinum in patients with stages III and IV previously untreated squamous cell cancer of the head and neck.
Forty-four patients were evaluated for ototoxicity following treatment with the chemotherapeutic agent cis-platinum. Statistically significant hearing changes at 2,000 Hz (p less than 0.001); 4,000 Hz (p less than 0.05); and 8,000 Hz (p less than 0.001) were observed. Chi-square analysis demonstrated that at 8,000 Hz patients who had lower than average thresholds prior to chemotherapy were more likely to experience greater threshold shift than those patients whose pre-chemotherapy thresholds were higher than average. In this patient sample, there was no significant correlation shown between serum creatinine levels and ototoxicity.
Adult↗
Phase II trial of cyclophosphamide, doxorubicin, and cisplatin (CAP) versus amsacrine in patients with transitional cell carcinoma of the urinary bladder: a Southwest Oncology Group study.
The combination of cyclophosphamide, doxorubicin, and cisplatin (CAP) was reported to be effective in patients with metastatic transitional cell cancer of the urinary bladder. This study was designed to test the effectiveness of the phase II agent amsacrine (m-AMSA) versus CAP in patients previously untreated with systemic chemotherapy, with crossover if no response occurred or at the time of progression. In 23 patients who were randomized to receive CAP, three achieved complete response, seven achieved partial response, six had stable disease, and seven had disease progression. The responses in the 22 patients who received m-AMSA were: one with complete response, three with partial response, six with stable disease, and 12 with progressive disease. The overall response rate to initial CAP therapy was 43% compared to 19% for initial m-AMSA therapy. The median duration of response to CAP was 28 weeks and to m-AMSA was 21 weeks. There were no statistically significant differences in the durations of response or survival times between the groups. The main side effects of CAP were: nausea and/or vomiting, leukopenia, anemia, thrombocytopenia, and renal toxicity. Leukopenia and anemia were the major toxic effects of m-AMSA. Our study supports the justification for testing phase II agent(s) in previously untreated patients with bladder cancer with systemic chemotherapy, provided adequate crossover to a known active single or combination of agents is built into the design of such a trial.
Aged↗
The role of induction chemotherapy in advanced head and neck cancer: the Wayne State University experience.
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Antineoplastic Combined Chemotherapy Protocols↗
Correlation between response to cisplatinum-combination chemotherapy and subsequent radiotherapy in previously untreated patients with advanced squamous cell cancers of the head and neck.
Induction chemotherapy, followed by surgery and/or radiotherapy was utilized in patients with advanced squamous cell carcinoma of the head and neck. During these trials, the authors observed that response to chemotherapy predicts further response to subsequent radiotherapy. This study was comprised of 57 patients with 60 separate neoplasms who demonstrated less than complete response (partial or no response) to initial treatment with a combination chemotherapy containing cisplatin. Subsequently radiotherapy, either 5000 rad preoperatively or 6600 rad as definitive therapy, was employed. Forty-one of the 42 tumors with initial partial response to chemotherapy also responded to radiotherapy (97.6%). Only one of the 18 tumors that initially failed to respond to chemotherapy subsequently responded to radiotherapy (5.5%). This observation suggests that patients with head and neck cancer sensitive to initial chemotherapy share parameters that are also radiation sensitive.
Antineoplastic Combined Chemotherapy Protocols↗
Cisplatin and 5-fluorouracil infusion in patients with recurrent and disseminated epidermoid cancer of the head and neck.
The combination of cisplatin and 96-hour infusion of 5-fluorouracil (5-FU) was evaluated in 30 patients with recurrent (local and regional) and disseminated histologically proven epidermoid cancer of the head and neck who failed surgery and radiotherapy. Cisplatin 100 mg/M2 intravenous (IV) bolus was given on day 1 with hydration and mannitol diuresis; 5-FU 1000 mg/M2 per day for 96-hour infusion was started immediately after cisplatin on day 1. All patients had measurable lesions. Eight (27%) patients achieved complete response (CR), and 13 (43%) had partial response (PR). Overall response rate was 70% (8 of 30 CR and 13 of 30 PR). Response rate in patients with recurrent local and regional disease was 89% (17/19) with median survival of 32 weeks, while response in patients with disseminated disease was 36% (4/11) with median survival of 24 weeks. Patients with good performance status (PS) (greater than or equal to 70%) had a response rate of 79% (19/24), while those with poor PS (less than 70%) had a response rate of 33% (2/6). Seven patients with recurrent disease who had a response to this chemotherapy went to further salvage surgical procedures. It is concluded that the combination of cisplatin and 5-FU is very effective and well tolerated in these patients, and leads to further salvage in some patients with improved longevity and quality of life.
Adult↗
Computerized bone scan. A potentially useful technique to measure response in prostatic carcinoma.
Computerized bone scanning (CBS), a technique used to measure quantitative changes in bone scans, is described. Ten patients with histologically proven metastatic carcinoma of the prostate had sequential CBS performed. Good correlation was found between marked improvement in CBS (more than 50% average decrease in counts) and objective responses. Two patients had partial remission with more than 50% average decrease in uptake by prostatic cancer project criteria; both of them had good pain control. Three patients had worsening of their disease by CBS, which correlated with other parameters of disease progression (new lesions in bone survey, loss of weight and poor survival). In those patients with less than 50% average change the correlation is not so clear cut. An increase in percentage of uptake occurs in the first month after beginning of therapy, and no significant change is observed until 3 months. CBS is a technique that allows for objective measurement of quantitative changes in bone uptake, which is potentially useful for the evaluation of response to treatment in patients with metastatic bone disease from carcinoma of the prostate.
Acid Phosphatase↗
Combination chemotherapy plus levamisole in the treatment of disseminated malignant melanoma. A Southwest Oncology Group study.
Two hundred-eighty patients were randomized to receive either BCNU, hydroxyurea and imidazole carboxamide (BHD), BHD plus levamisole, or high-dose DTIC plus actinomycin D. There was no difference in response rate in the three groups (24%, 25% and 22%). Females responded better than males and, as expected, those with a better performance status responded more favorably than those with poor performance status. Patients whose primary site of melanoma was on the extremities did significantly better than those melanomas originating on the trunk or head and neck. Patients with lymphocyte counts greater than 2000/mm3 fared better than those with lymphopenia. Those responders who received high-dose DTIC plus actinomycin D had a significantly longer length of response than those receiving the immunotherapy limb. This was also true in those patients who had a prior disease-free interval of greater than 6 months before being placed in this study. Although there was no difference in survival from the start of treatment in all patients, those patients receiving high-dose DTIC plus actinomycin D and who had a prior disease-free interval of greater than 6 months, had significantly superior survival when compared to the immunotherapy limb. It is concluded that the addition of Levamisole to BHD does not improve response rate and may in certain subsets be detrimental to disease-free response and survival. High-dose DTIC plus actinomycin D is equally effective to BHD.
Antineoplastic Combined Chemotherapy Protocols↗
Lymphoma of the frontal sinus. Case report and review of literature.
A 43-year-old woman had an unusual case of non-Hodgkin's lymphoma (NHL) of the frontal sinus. Although the tumor was not diagnosed until after gross intracranial extension had already occurred, the patient's condition responded excellently to surgical debulking, frontal sinus obliteration, and chemotherapy. To date, she has had no neurologic sequelae or evidence of recurrence. In the past, stage 1 and 2 NHL of the nasal cavity and paranasal sinuses has been treated with primary radiation therapy, but a review of the literature shows that treatment failure is common in these cases.
Adult↗
Superior clinical response and survival rates with initial bolus of cisplatin and 120 hour infusion of 5-fluorouracil before definitive therapy for locally advanced head and neck cancer.
One hundred ninety-one patients were treated by one of three cisplatin-containing multidrug protocols. The initial 77 patients received two courses of cisplatin and vincristine plus bleomycin. The next 26 patients received two courses of 5-fluorouracil and cisplatin, and the final 88 patients were placed on a three course 5-fluorouracil and cisplatin protocol. Overall response rates were similar for each of the three protocols. The complete response rate, however, was much better (54 percent) for three course 5-fluorouracil and cisplatin versus cisplatin vincristine, and bleomycin (29 percent) and two course 5-fluorouracil and cisplatin (19 percent). Survival curves were also better for the three course 5-fluorouracil and cisplatin segment of this nonrandomized pilot study.
Adolescent↗
Chemotherapy strategies in squamous cell carcinoma of the head and neck.
Traditionally, chemotherapy has been utilized in the palliation of patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The introduction of more effective agents has spawned many new multi-drug protocols as the initial therapy of patients with previously untreated advanced cancers (Stages III and IV). The combination of cis-platinum and other active agents given in two to three courses has produced overall response rates of 80 to 90% with clinically complete response rates of 20 to 54%. Many of the complete responders were histologically negative for cancer at the time of resection. The number of courses, stage (T and N), and tumor morphology influenced the complete response rate to combination chemotherapy. Responders to chemotherapy had statistically improved survival as compared to nonresponders. Response to chemotherapy was an excellent predictor for subsequent response to radiotherapy. Utilizing the same combination of chemotherapy, we improved the overall response rate in those patients with recurrent and systemic cancer. Although the median survival is still poor, there is improvement of survival at 25 percentile level. Some of the important factors that may influence the response rate and the survival of these patients are performance status, previous radiotherapy, and whether the recurrence is localized or systemic.
Antineoplastic Combined Chemotherapy Protocols↗
Phase II evaluation of aclacinomycin-A (NSC-208734) in adenocarcinoma of the kidney.
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Aclarubicin↗
Aclacinomycin. Phase II evaluation in advanced squamous carcinoma of the head and neck.
Aclacinomycin-A was evaluated in a phase II trial for advanced head and neck cancer. A weekly infusion of 65 mg/m2 was used. Eighteen patients were entered. Fifteen patients were evaluable for response and toxicity. One was evaluable for toxicity only and two died before completion of a full course of therapy. One patient without previous chemotherapy achieved a PR in a neck node for a short time. Six patients had stable disease with a median to progression of 6 weeks. Major toxicity encountered was bone marrow suppression. Aclacinomycin-A appears to have no activity in squamous cancer of the head and neck.
Aclarubicin↗
Hypercalcemia in head and neck carcinoma. Incidence and prognosis.
A retrospective review of all head and neck cancers seen between January 1, 1975, and September 1, 1981, at Harper-Grace Hospitals, Detroit, Michigan, was performed. Of 1438 patients with head and neck cancers, 41 (2.9%) had hypercalcemia (calcium greater than 11.0 mg%) during the course of their disease. The incidence of hypercalcemia by site was 13 of 351 (3.7%) larynx, 7/280 (2.5%) pharynx, 19/733 (2.6%) oral cavity (floor of mouth 4/171, tongue 9/209, tonsil 5/176, palate 1/95, other 0/82, 2/26 (7.7%) nasal cavity, and 0/48 salivary gland carcinomas. Chest radiograph results were positive for mass lesions in 17/35 (49%). Bone scans and/or x-ray results were positive in 15/31 (48%), negative in 16/31 (52%), and were not evaluated in 10 patients. Of five patients tested, all had inappropriately elevated serum parathyroid hormone (PTH) for their serum calcium level. The hypercalcemia was medically treated in 29/41 (70%), with return-to-normal calcium levels in 17/29 (59%). Twelve patients (30%) received only terminal care. Survival from the diagnosis of hypercalcemia ranged from 1 to 514+ days (mean, 80+ days; median 33 days). It is concluded that hypercalcemia is unusual in head and neck carcinoma. Furthermore, hypercalcemia frequently is a late manifestation and terminal event. Finally, hypercalcemia in some patients may be mediated by PTH production.
Head and Neck Neoplasms↗
Chemotherapy for nasopharyngeal carcinoma. A ten-year experience.
Seventeen patients, 14 after radiation therapy relapse, with measurable nasopharyngeal carcinoma were treated with chemotherapy. Remissions were observed in 9 of 17 (53%) with 3 complete (CR) and 6 partial responses (PR). Five (2 CR + 3 PR) of seven patients with lymphoepithelioma achieved remission, 4 (1 CR + 3 PR) of 8 with keratinizing squamous cell carcinoma, and 2 progressions with transitional cell carcinoma. Complete remissions were only achieved with CDDP-based combinations, with 2 of the 3 CR rendered histologically free of disease at the time of repeat biopsy of the tumor bed. Nasopharyngeal carcinoma is responsive to chemotherapy, even after radiation therapy relapse. The most effective chemotherapy combinations contain CDDP. Histologic differentiation did not appear to influence the frequency of remissions.
Adolescent↗