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Biomedical subjects

J Ensley

Publications and source records attributed to J Ensley.

27 records · Page 2Linked to original sources
PubMed1988

An intensive, five course, alternating combination chemotherapy induction regimen used in patients with advanced, unresectable head and neck cancer.

Progress in the treatment of advanced squamous cell cancer (SCC) of the head and neck (H & N) has included the development of combination chemotherapeutic regimens that achieve impressive complete response (CR) rates using two to three courses therapy with minimal toxicity and good patient tolerance. Further improvements in these results will require intensification of induction regimens. Therefore, a five course, alternating combination chemotherapy induction trial was initiated in an attempt to test the feasibility and toxicity of a prolonged, intensive induction regimen in patients with advanced SCC of H & N. Courses 1, 3, and 5 consisted of fluorouracil as a 120-hour infusion (5FU-I) with cisplatin (CACP) as an intravenous (IV) bolus. Courses 2 and 4 consisted of 3 weekly doses of high-dose methotrexate (HDMTX) followed by 5FU (5FU-b) and leucovorin rescue (LR). Forty-six stage IV patients with SCC of H & N (85% T4 and 58% N3) were entered. Thirty-one patients completed the study and 15 did not. Twenty-one of the 46 patients (46%) achieved a CR. Twenty-five of the 46 patients had N3 neck disease, ten of these 25 achieved a CR (40%), and eight did not complete therapy. Of the 15 patients not completing this study, one patient achieved a CR and eight achieved a partial response (PR). Eight of 46 (17%) were removed from study for reasons of toxicity (6% to 13%) or tumor progression (2% to 4%). The remaining seven were removed due to intercurrent medical conditions (four uncomplicated pneumonias and one gun shot wound) or lost to follow-up (2). Myelosuppression, mucositis, and skin toxicity increased in frequency by the end of the trial but were acceptable and reversible. The activity of this five-course regimen is promising given the advanced disease status of patients treated. Consideration of concurrent medical conditions, patient compliance, intensity of medical, nutritional and social support, and levels of acceptable toxicity will be necessary in the design of future, intensive induction trials.

Adult↗
PubMed1987

Achievement of superior survival for histologically negative versus histologically positive clinically complete responders to cisplatin combination in patients with locally advanced head and neck cancer.

In a series of three consecutive pilot studies conducted between 1977 and 1982 at Wayne State University, Detroit, Michigan, 191 consecutive patients with previously untreated, locally advanced head and neck cancer were treated with cisplatin (CDDP), vincristine, and bleomycin or CDDP and 5-fluorouracil (5-FU) infusion before definite surgery or radiation. A 39% (75/191) rate of complete clinical responses was achieved. Thirty-two of the chemotherapy-induced complete responders underwent radical surgery. Thirteen had no histologic evidence of residual disease in the surgically resected specimen. The CDDP and 5-FU infusion combination achieved the highest histologic complete response rate. All histologically complete responders who had completed local radiation therapy are clinically free of disease at median follow-up of 36 months. Patients who achieved complete response both clinically and histologically had superior survival as compared to patients who achieved complete response clinically and were subsequently found to have residual tumor in their surgically resected specimen (P = 0.01). An analysis of the clinical and pathological pretreatment characteristics was performed to identify factors predictive of histologic complete response. Advanced nodal disease correlated inversely with the achievement of negative histology in the surgically resected specimen (P = 0.02). No other factors were significant in predicting response.

Adult↗
PubMed1987

5-Fluorouracil cardiotoxicity: left ventricular dysfunction and effect of coronary vasodilators.

Seven patients developed clinical features simulating myocardial ischemia less than 72 hours after 12 of 13 separate intravenous 5-fluorouracil administrations; 9 episodes were associated with chest pain, 3 with hypotension, 3 with ventricular tachycardia and 1 with cardiogenic shock. Left ventricular dysfunction was demonstrated by echocardiography in 5 separate episodes, 2 with interval improvement upon repeat echocardiograms. Pretreatment with nitrates and/or calcium channel blockers failed to prevent recurrence of cardiotoxicity during 5 of 6 repeat 5-fluorouracil administrations. Therapy with 5-fluorouracil is associated with cardiotoxicity simulating myocardial ischemia with left ventricular dysfunction. Pretreatment with coronary vasodilators may not prevent this phenomenon.

Aged↗
PubMed1986

The activity of a single-agent 5-fluorouracil infusion in advanced and recurrent head and neck cancer.

Although chemotherapy regimens using cisplatin (CDDP) and 5-fluorouracil (5-FU) infusion have shown significant activity in advanced and recurrent head and neck cancer, their use requires normal renal function. The use of 5-FU infusion alone has not been evaluated in these tumors. Retrospective analysis revealed 11 patients who received 5-FU infusion alone because of poor renal function: 7 patients with recurrent disease who were previously treated with surgery and/or radiation therapy and 4 patients who received 5-FU as preoperative induction therapy for advanced disease were treated. The infusion dose consisted of 1000 mg/M2/24 hours for 96 hours for patients with previous radiation and 120-hour infusions for patients without previous radiation. The courses were repeated at 3-week intervals. Eight of 11 (72%) demonstrated a response (1 complete response [CR] and 7 partial responses [PRs]. Responses occurred in 4 of 4 (all PRs) patients with previously untreated epidermoid cancer, 1 patient with recurrent adenocystic cancer, and 3 of 6 patients with recurrent epidermoid cancer not previously treated with chemotherapy. Three patients, with no prior systemic or local therapy, who were clinical partial responders to 5-FU infusion went on to surgery and radiotherapy. Their responses were maintained for 18, 14, and 46+ months, respectively. The predominant toxicities were stomatitis (6/11, 55%) and leukopenia (2/11 patients). In this retrospective analysis, 5-FU infusion alone demonstrated good activity in head and neck cancer with tolerable toxicity. Since the number of patients is small and were selected on the basis of renal function, prospective evaluation is essential.

Aged↗
PubMed1986

The impact of conventional morphologic analysis on response rates and survival in patients with advanced head and neck cancers treated initially with cisplatin-containing combination chemotherapy.

The response to initial treatment with cisplatin-containing combination chemotherapy as well as survival, were correlated with tumor differentiation (well, moderate or poorly differentiated) in 164 patients with advanced, untreated squamous cell carcinoma of the head and neck. Thirty-three percent of the tumors were graded as poorly differentiated, 59% moderately differentiated, and 8% were well differentiated. The overall clinical response rates were nearly equal for the three grades of differentiation: 79% for well differentiated, 86% for moderately differentiated, and 89% for poorly differentiated. The complete response rate was somewhat higher for poorly differentiated tumors: 46% as compared to 32% and 29% for moderately and well differentiated respectively, but the differences were not statistically significant. The median survival for each morphologic group was 22, 16, and 12 months for well differentiated, moderately differentiated and poorly differentiated tumor, respectively (P = 0.097). For patients achieving a complete clinical response to chemotherapy, there was a difference in survival when stratified according to degree of histologic differentiation. Patients who were complete responders and had well or moderately differentiated tumors attained 75% and 38% survival at 36 months, respectively, versus 19% for patients with complete response and poorly differentiated tumors (P = 0.064). The degree of differentiation of previously untreated squamous cell cancers of the head and neck does not conclusively predict tumor response to combination chemotherapy, but may reflect differences in natural history. Survival is improved in patients with differentiated tumors as compared to those with poorly differentiated tumors. Morphologic grading in patients achieving a complete response reveals a decrease in survival for patients with poorly differentiated tumors.

Adult↗
PubMed1984

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↗
PubMedDate not supplied

Platinum analogs in recurrent and advanced head and neck cancer: a Southwest Oncology Group and Wayne State University Study.

Cisplatin combinations are active in patients with epidermoid cancer of the head and neck. Because of the incidence of dose-limiting toxicity and the need for hospitalization for iv hydration and mannitol diuresis, the search for active analog(s) with less of such toxicity has been intensive. In a limited institution study of Wayne State University and the Southwest Oncology Group, a clinical trial of carboplatin (CBDCA) and iproplatin (CHIP) in patients with recurrent head and neck cancer was carried out. Sixty-four patients were entered and 63 were evaluated, 29 receiving CBDCA and 34 receiving CHIP therapy. These patients were stratified according to important prognostic factors. The response rate to CBDCA was 24% (seven responses among 29 patients; three complete responses and four partial responses), and to CHIP was 12% (four responses among 34 patients; one complete response and three partial responses). Both drugs were administered without prior hydration or mannitol diuresis on an outpatient basis. The major side effect was myelosuppression, which was reversible but cumulative and dose-limiting. Less severe vomiting occurred as compared to the incidence of this toxicity with cisplatin and no significant renal or hearing loss occurred. It was concluded that further evaluation of these agents with other active drug(s) in patients with head and neck cancer is warranted.

Adult↗