Jay Herson

Radiation necrosis of the mandible: A 10 year study. Part I. Factors influencing the onset of necrosis

Abstract Of 404 patients who were irradiated for cancer in the oral region between 1971 and 1975, 19.1 % developed radiation necrosis of the mandible. Three main effects, anatomic tumor site, tumor dose, and dental status, were found to have a statistically significant effect on incidence of necrosis. Necrosis was also found to occur more frequently in association with an implant than with treatment administered by an external radiation source alone. The T-stage of the tumor did not appear to affect the incidence of necrosis. Necrosis incidence was also studied over two time periods- 1966-1%9 (study I) and 1971–1975 (study II). Differences between the two periods were found in the primary etiological groupings. Necrosis attributed to spontaneous or unknown cause increased in the second study, while that associated with dental extractions before irradiation decreased. Fewer teeth were extracted before radiation therapy in study If than in study 1. Less necrosis followed mandibular surgery for recurrent disease in study II than study 1.

Radiation necrosis of the mandible: A 10 year study. Part II. Dental factors; onset, duration and management of necrosis

Abstract In a review of patients receiving radiation for cancer in the oral region the rate of radiation necrosis of the mandible was found to be similar for patients who had dental extractions before radiation therapy and for the remainder of the dentate population. It was suggested that diseased teeth should be removed prior to irradiation and sufficient healing time should be allowed. Teeth should not be extracted after irradiation. Dental prostheses can be provided for most irradiated patients if adequate care is exercised. The probability of necrosis commencing was highest three to twelve months after the start of therapy, it diminished gradually after that period. The duration of necrosis was depicted as an exponential curve with a constant probability of necrosis termination at each time point after onset. In 46.8 % of the patients in study II (1971–19751, the necrosis was healed by conservative means. This was a significant increase over study I (1966–1969), and a complementary reduction in the necessity for surgical intervention was also found.

Hexamethylmelamine: An evaluation of its role in the treatment of ovarian cancer

Hexamethylmelamine (HMM), NSC 13875, a synthetic agent structurally related to triethylenemelamine, has clinical antitumor activity and a role in the treatment of ovarian cancers of epithelial origin. Fifty-four patients, with International Federation of Gynecology and Obstetrics Stage III or IV carcinomas, previously untreated with chemotherapy or irradiation therapy, were treated with HMM (8 mg/kg/day) as a single agent at the M. D. Anderson Hospital and Tumor Institute in Houston, Texas, between January, 1973, and May, 1976. The response end points analyzed were complete plus partial response rate, duration of remission, and survival time. The complete and partial responses were verified whenever possible by second-look operation. Seventeen patients (31.8%) responded to HMM and three had no evidence of cancer, determined by multiple biopsies at second-look operation. Gastrointestinal, hematologic, and nervous system toxic effects were severe in 10 patients, requiring discontinuation of HMM. This study shows that HMM can induce a complete response and provide an extended disease-free interval without maintenance chemotherapy.

Favorable response to maintenance therapy of second or subsequent remissions in childhood acute lymphocytic leukemia

Twenty‐two children with acute lymphocytic leukemia (ALL) who had relapsed while on therapy and for whom remissions were successfully reinduced were maintained with a combination of methotrexate, daunomycin, 6‐mercaptopurine, prednisone, and vincristine (Djerassi‐methotrexate with BOMB). The median duration of remission was 35 weeks (range, five to 364+ weeks). Of 8 children (36%) did not relapse while receiving this therapy, 4 are off all therapy (durations of remission, 40+, 97+, 132+, and 216+ weeks). Improved responses were found in children with platelet counts of greater than 105/mm3 at the time of index relapse. Intrathecal chemotherapy seemed to greatly prolong the duration of remission for 16 children when compared to those children who did not receive IT therapy (45.5 vs. 24 weeks). No central nervous system relapses occurred. This maintenance regimen for children with previously relapsed ALL appears to be effective and worth additional clinical trials.

Single-Agent Adriamycin Followed by Combination Hexamethylmelamine-cyclophosphamide for Advanced Ovarian Carcinoma'

Abstract Singleagent Adriamycin (ADM) induced a 21.8% response rate, surgically documented, in 32 previously untreated patients with advanced ovarian cancer. Patients with grade 3 carcinomas had a longer survival time than patients with grade 2 carcinomas ( P = 0.07). A statistically significant interaction of grade and age was found ( P = 0.01). Patients younger than 45 years had almost precisely the same risk of death per unit time, regardless of grade. Patients over age 45, with grade 3 tumors, had 3.6 times the risk of death per unit time, and those with grade 2 tumors had 45.5 times the risk as the patient under 45 years of age. Hexamethylmelamine-cyclophosphamide was active in four patients (17%) who failed to respond to ADM. ADM may exert significant but selective anti-tumor activity and deserves additional testing in drug combinations used in the treatment of ovarian cancer.

Patient registration in a cooperative oncology group

Patient registration in a cooperative oncology group refers to the process by which a patient diagnosed at a member institution of the group is entered into the groups records for a selected clinical trial and, where applicable, is issued a random treatment assignment. Patient registration in a cooperative oncology group should not be limited to the routine clerical activities of compiling lists of patients entered on studies and supplying random numbers for treatment assignments. After background material on cooperative oncology groups and statistical issues are presented, the objectives of patient registration are defined to include initiation of data collection, randomization of patients, quality control (enforcing protocol adherence, reduction of bias, suggestion of needed protocol amendments, and evaluation of institutional performance), and planning future clinical trials (providing estimates of patient accrual and providing advice on registration matters). Various administrative procedures found useful in fulfilling these objectives for both randomized and nonrandomized clinical trials that are neither single nor double blind are presented . Foremost among these are the creation of a centralized patient registration staff employing extended telephone registration and a monitoring of patient registration activities through a monthly report system.

An Investigation of Relative Efficiency of Least- Squares Prediction to Conventional Probability Sampling Plans

Abstract A particular finite population, typical of the type encountered in practice, is used to assess the efficiency of ratio estimation of the finite population total using conventional unrestricted random sampling, extreme and balanced sampling plans, for samples of size 10, 50, 100, and 200. The balanced sampling plans are seen to be as much as 30 percent more efficient than the corresponding unrestricted random sampling plan regardless of sample size, but the extreme sample is inferior to both of these plans.

Virus-modified homologus tumor-cell extract in the treatment of vulvar carcinoma

SummaryEight patients with squamous carcinoma of the vulva and two or more positive nodes have received adjunctive immunotherapy with a virus modified homologous cell extract. Seven of eight patients received radiation therapy in addition. Cells derived from the SW962 vulvar carcinoma cell line were infected with PR8/A/34 strain of influenza and a membrane extract was used for immunization. The extract was administered by the intradermal route weekly for three doses and then biweekly for up to 2 years. Each dose is equivalent to 1.5 mg protein. None of the patients have recurred and durations of remission are 24, 24, 22, 22, 21, 16, 7, and 2 months respectively. This compares favourably with similar groups of patients who were treated with surgery alone (22/33 recurred, median recurrence time 14.8 months) or surgery plus radiation therapy (8/9 recurrences, median recurrence time 11.0 months). No serious side effects have occurred with more than 200 doses of extract.Post immunization monitoring has indicated good in vitro and in vivo immunological responses and antibody titers to PR8 increased significantly in five of eight patients.

Bleomycin and mitomycin‐C (BLM‐M) in recurrent squamous uterine cervical carcinoma

Bleomycin and mitomycin‐C (BLM‐M) induction therapy was administered to 23 patients with recurrent squamous carcinoma of the uterine cervix. Six patients (26%) responded. Although these results are much lower than originally reported with BLM‐M, there is statistical evidence that patients with disease outside the previous radiation therapy field have improved or more easily determined responses. There was no difference in survival between responders and nonresponders for patients who survived at least six weeks. Therapy was found to be relatively nontoxic with no deaths related to therapy.

Tumor antigenicity and the immune system in gynecological cancer: A review

Abstract A review of tumor immunology with particular emphasis on three gynecological malignancies, gestational trophoblastic disease, uterine cervical carcinoma, and ovarian carcinoma. Commentary includes the immune reactive cells and their functions as determined by in vitro and in vivo tests; serum and tissue antigen markers; and effects on the immune response of ionizing radiation, surgery, and chemotherapy.