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Objective: There is a paucity of information in the literature about how electromyography (EMG) with nerve conduction studies (NCS) can be utilized in the field of neurolaryngology. The goal of this study was two-part: (1) to identify the NCS test parameters that best reflect underlying neurolaryngeal pathophysiology in a porcine model, and (2) to determine if comparable NCS parameters can be used to assess clinical laryngeal denervation injuries in patients., Methods: Yukatan minipigs underwent general anesthesia with EMG and recurrent laryngeal NCS assessment. Recurrent laryngeal nerve (RLN) transection injury and uninjured RLN cases were included to determine NCS neuropathologic and normative findings, respectively. Our porcine analytic model was then applied to a clinical scenario of seven patients with RLN injury., Results: The porcine model was able to differentiate and characterize normative and neuropathologic NCS changes. Clinical outcomes suggest that RLN NCS can be performed clinically and is overall well tolerated by in patients. Findings may serve as a useful tool to differentiate normal nerve function, neuropraxia, axonotmesis, and irreversible RLN injuries., Conclusion: This novel study is the first to demonstrate the feasibility and applicability of EMG with NCS in the evaluation of vocal fold function in a porcine model in addition to the clinical setting. Further studies are needed to better understand the clinical utility and predictive value in recovery of vocal fold paralysis., Competing Interests: Declaration of Competing Interest The authors have no relevant conflicts of interest to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Nerve conduction studies are a key component of the electrophysiologic evaluation of the peripheral nerve system, and provide important information about the integrity of the large, myelinated axons, neuromuscular junctions, and muscle. Nerve conduction studies involve eliciting nerve action potentials at sites along a peripheral nerve and recording the response from another site along the nerve or from a muscle innervated by that nerve. Attention to details of test performance, use of well-established normative values, and knowledge of the patterns of abnormality produced by disorders that affect neuronal, axonal, and myelin sheath function are fundamental for proper interpretation of results., Competing Interests: Disclosure Textbook author, Prahlow, ND, Kincaid, JC. Rehabilitation Medicine Quick Reference, Neuromuscular. RM, Buschbacher, Editor. New York: Demos Medical Publishing; 2014., (Copyright © 2021 Elsevier Inc. All rights reserved.)

There is increasing interest in evaluating the impact of cancer treatment and medical intervention on patient quality of life (QOL). This article reports the findings of a substudy that incorporated the Functional Living Index--Cancer in an ongoing adjuvant breast cancer clinical trial sponsored by the Southwest Oncology Group. The companion study had to be terminated prior to the end of the two-armed, randomized trial because of poor reporting rates over time. Problems with missing data items also occurred. Poor reporting rates in this trial motivated several recommendations for conducting QOL assessment in the cooperative group setting: (a) build support for QOL assessment among the group's leadership, (b) involve physicians and oncology nurses in the study design, (c) identify a QOL liaison at each participating institution, and (d) aggressively monitor the quality and timeliness of data submission.

Purpose: To determine if prolonged adjuvant treatment (2 years v 1 year) with combination chemotherapy (cyclophosphamide, methotrexate, fluorouracil [5-FU], vincristine, and prednisone [CMFVP]) in poor-prognosis breast cancer patients (estrogen receptor [ER]-negative, stage II to IIIA) would result in improved disease-free and overall survival rates., Patients and Methods: Four hundred forty-five women with ER-negative node-positive breast cancer were enrolled by the Southwest Oncology Group (SWOG) over a period of 5 years (1979 to 1984). Randomized assignments were made to either 1 or 2 years of adjuvant CMFVP. Doses were daily oral cyclophosphamide 60 mg/m2, intravenous (i.v.) weekly methotrexate 15 mg/m2, i.v. weekly 5-FU 400 mg/m2, i.v. weekly vincristine .625 mg/m2 for the first 10 weeks, and prednisone weeks 1 through 6 with doses decreasing from 30 mg/m2 to 10 mg/m2., Results: The median follow-up duration is 8.6 years, with a maximum of 11.3 years. Treatment arms were not significantly different as regards either survival or disease-free survival rates (P = .33 and P = .24, respectively). The five-year survival rate is 57% on the 1-year arm and 62% on the 2-year arm. Patients with three or fewer nodes and premenopausal status were associated with improved survival. Compliance on the 2-year arm was poor, with only 37% completing the full 2 years of treatment. SWOG grade 3 to 4 toxicity was experienced by 47% of patients on the 1-year arm and by 52% on the 2-year arm. There were no treatment-related deaths., Conclusion: We conclude that 2-year adjuvant treatment with CMFVP is not an improvement over 1-year treatment. Moreover, 2 years of CMFVP is difficult to complete. However, the results are not definitely negative. A moderate improvement attributed to prolonged chemotherapy, especially among patients with four or more positive nodes, cannot be ruled out.

Twenty-two patients are evaluable for response in a Phase II trial of Mitoxantrone for advanced squamous cell carcinoma of the head and neck. One patient had a partial response, one an improvement and twenty had progressive disease. The major toxicities were leukopenia and thrombocytopenia. There was no significant antitumor activity of Mitoxantrone in this group of patients with head and neck cancer, most of whom were previously treated with radiation and chemotherapy.

One hundred and fifteen eligible patients with histologically verified malignant gliomas (astrocytoma grade III-IV) were randomized to receive either radiotherapy 6 000 rads/7 week plus CCNU 130 mg/M2 every 6 weeks (treatment 1) or radiotherapy 6 000 rads/7 weeks plus CCNU 75 mg/M2 day 1 plus procarbazine 100 Mg/m2 days 1-14 every 6 weeks (treatment 2) within 4 weeks following surgical resection. The response rates showed no statistically significant differences between treatment 1 CR/PR - 24/17% and treatment 2 CR/PR - 14/14% (P-value = 0.31). The median survival was also not significantly different: 55 and 50 weeks for treatments 1 and 2, respectively. The most important prognostic parameter identified was age with younger patients showing higher response rates and longer survival. Patients' performance status was also a useful prognostic parameter for response and survival. Neither the extent of surgical resection nor the tumor grade correlated significantly with the outcome. Further studies are needed to identify active chemotherapeutic agents for the treatment of brain tumors.

A phase II study utilizing 5-azacytidine in the treatment of patients with solid tumors was carried out by the Southwest Oncology Group (SWOG-7208). Of 214 patients entered in the study 191 were eligible and 167 were evaluable. While initially they received 225 mg/m2 iv on Days 1--5 every 3 weeks because of toxicity the dose was subsequently reduced to 175mg/m2 and later to 150 mg/m2. Five partial regressions, 2.6% of the eligible patients and 3% of the evaluable patients, lasting from 28 to 77 days were observed. Sixteen patients 8.4% of the eligible patients and 9.6% of the evaluable patients, had no significant change in their disease for 39--255 days. The major toxicities were myelosuppressive and gastrointestinal with 13 deaths attributable to drug toxicity: 11 due to sepsis and two due to cerebral hemorrhage. 5-Azacytidine induced few favorable responses; those that did occur usually were of poor quality and short duration and were associated with significant toxicity.

Twenty-three patients with heptocellular carcinoma were treated with m-AMSA at a dose of 120 mg/m2 iv repeated at 4-week intervals. Toxicity was primarily hematologic. Partial responses occurred in two of 14 previously treated patients and in one of nine previously untreated patients. The overall activity of m-AMSA in patients with hepatocellular carcinoma appears minimal.

The southwest oncology group tested cis-platinum, given in 28-day courses of 50 mg/m2 twice, a week apart, in patients with epidermoid carcinoma of the esophagus. Currently 19 patients entered on the study are evaluable for response (15 fully evaluable). Of these, two attained complete disappearance of tumor and four had partial responses. Of the remainder, two had stable disease lasting in excess of 90 days. Hematologic toxicity has been minimal except that three patients required multiple blood transfusions for anemia not due to blood loss. Of 21 patients currently evaluable for renal toxicity, nine had mild, and three had moderate azotemia. These results suggest that, unlike what has been believed in the past, squamous cell carcinoma of the esophagus is not a chemotherapy-resistant tumor. Further evaluation of cis-platinum alone and in combination with radiotherapy and surgery are in progress.

The Southwest Oncology Group evaluated 51 patients with a histologic diagnosis of metastatic adenocarcinoma and an occult primary tumor. Even though all patients received an extensive diagnostic evaluation, only six (12%) primary sites were found. Thirty-six patients whose primary tumor sites remained occult were randomized to receive either 5-FU or combination chemotherapy (5-FU, doxorubicin, and cyclophosphamide [FAC]). There were no responses in either group. The median survival with 5-FU was 105 days and with FAC was 95 days. Toxicity with FAC was more common and more severe.

Because "the standard" chemotherapy for advanced gastric adenocarcinoma, the FAM combination of 5-fluorouracil, adriamycin, and mitomycin, is only minimally effective, there is a clear need for other choices. Therefore, the Southwest Oncology Group tested the new adriamycin analog, bisantrene, hoping that it might be more effective than the "parent drug." Twenty-six patients with gastric adenocarcinoma were treated on a program of every-3-week 2-hour bisantrene infusions. The starting dose was 260 mg/m2 (208 if poor risk), with subsequent doses based on prior toxicity. The regimen caused sufficient toxicity (especially local phlebitis with pain and swelling) to assure an adequate test. One person (3.8% of eligible patients) experienced a clinically useful 3-month response. He had previously had progressive disease on FAM. Nevertheless, we conclude that bisantrene is not an addition to the small list of drugs useful in the management of gastric adenocarcinoma.

Iv Baker's antifol (BAF) (250 mg/m2/day X 3 consecutive days) was administered to 34 patients with metastatic sarcoma. All patients had received extensive prior therapy including prior chemotherapy and had progressive disease at the start of the study. Liver and renal functions were normal in all patients. Of 29 patients evaluable for response, 25 demonstrated progressive disease and four had stable disease for periods of from 1 to 6 months. No objective responses were observed. The other five patients died from 3 to 12 days after initiation of therapy. Toxicity included myelosuppression of significant degree in nine patients, gastrointestinal effects of nausea and vomiting in seven, stomatitis in three, and dermatitis in four. Most toxicity was mild to moderate, although one drug-related death due to marked myelosuppression was seen. In conclusion, BAF is considered to be insignificantly active in the secondary treatment of metastatic sarcomas at the dose and schedule studied.

DTIC was one of the first of several new agents evaluated by the Southwest Oncology Group (SWOG) and the M.D. Anderson Hospital and Tumor Institute (MDAH) in the therapy of adult patients with metastatic sarcomas. It yielded an overall response rate of 17%. This is similar to that seen in a review of 138 patients who represent the total number reported in either published or unpublished data. The subsequent addition of DTIC to adriamycin in several studies carried out at the MDAH and in the SWOG has increased the complete and partial remission rate over that seen with adriamycin alone, and more importantly has increased remission duration and survival. DTIC is currently used in combination with adriamycin in the first-line therapy of patients with metastatic sarcomas and should be considered for patients who have relapsed on primary therapy not including DTIC.

A randomized trial was conducted by the Southwest Oncology Group (SWOG) in advanced carcinoma of the stomach and pancreas. Patients were assigned to receive monthly 5-fluorouracil 96-hour continuous infusions with either bolus mitomycin-C or oral methyl-CCNU. Mitomycin-C and methyl-CCNU were administered every eight weeks. The 5 FU-mitomycin combination produced a 14% and 22% response rate in disseminated stomach and pancreatic carcinoma, respectively. The combination of infusion 5 FU and methyl-CCNU achieved responses in 9% and 5% of stomach and pancreatic tumors, respectively. There was no significant difference in survival between limbs for either tumor. Median survival in gastric carcinoma on the 5 FU-mitomycin regimen was 25 weeks vs. 18 weeks on the 5 FU-METHYL-CCNU arm. In pancreatic carcinoma median survival on the mitomycin limb was 19 weeks as compared to 17 weeks on the methyl-CCNU program. Leukopenia was greater for the first course on the mitomycin limb. Regression analysis demonstrated that performance status was the most important pretreatment characteristic for predicting survival in both tumors. Neither 5 FU infusion combination appears to significantly alter the dismal prognosis of advanced upper gastrointestinal neoplasms.

One hundred twenty-two patients with advanced adenocarcinoma of the breast were randomized to receive adriamycin (AD) alone or a combination of VP-16 plus lower dose adriamycin (VAD). The patients were stratified to good and poor risk. The starting dose (day 1) of AD was 60 mg/m2 for good risk and 45 mg/m2 for poor risk. The starting dose of the VAD combination for the good-risk patient was VP-16, 75 mg/m2 daily x 5 plus adriamycin 35 mg/m2. The poor-risk dose for VAD was VP-16, 50 mg/m2 daily x 5 plus adriamycin, 30 mg/m2 on day 1. The total dose of AD was 450 mg/m2 on both arms. The patients who were on the VAD arm continued on VP-16 maintenance. Both arms were repeated every 21 days. There were 54 evaluable patients on the adriamycin arm and 52 evaluable patients on the VAD arm. Both arms were similar with regard to age, menopausal status, performance status, and prior hormonal therapy. More hematologic toxicity was seen in the adriamycin arm. Complete responses were observed on both arms, three (5%) with adriamycin and three (5%) with combination. Eleven (19%) and ten (18%) partial responses were observed with the adriamycin and VP-16 plus adriamycin, respectively. AD produced more stable disease than VAD (41% vs. 29%). Complete responses were seen only in the good-risk patients. Time to progression was delayed on the combination arm (P = 0.02). The survival in both arms was similar. The addition of VP-16 to adriamycin does not offer an important clinical advantage.

Thirty-one evaluable adults with recurrent astrocytomas were treated with Cisplatin 35 mg/m2 I.V. daily for three days every 3-4 weeks. All patients had previously been irradiated and most had previously received chemotherapy. Approximately half had poor performance status. Two patients experienced complete remissions and two additional patients experienced partial remissions. Three patients stabilized. Gastrointestinal toxicity was generally mild. Further studies are planned of Cisplatin in combination with other agents.

The Southwest Oncology Group has conducted a series of randomized studies of adjuvant therapy in patients with primary breast cancer and positive axillary nodes. The first study, during which combined chemotherapy with cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, and prednisone (CMFVP) administered for 1 year was compared with single agent therapy with melphalan (L-PAM) for 2 years, was activated in 1975 and closed in 1978. Of the 366 patients who were eligible, 191 received L-PAM and 175 were given CMFVP. The 2 groups were comparable with regard to known prognostic factors. At a median follow-up of 8 years, CMFVP continues to be superior to L-PAM in disease-free (P = .005) and overall survival (P = .01). Thirty-five percent of patients on CMFVP have died compared with 46% on L-PAM. The greatest survival benefit is apparent in premenopausal women and women with 4 or more positive axillary nodes. Acute toxicity was more frequent with CMFVP than with L-PAM, but it was acceptable and reversible with both regimens. Long-term toxicity was limited to myeloproliferative disease in 2 patients on L-PAM and 1 on CMFVP. The second-generation series of studies, activated in 1979, were designed according to nodal status, estrogen receptor (ER) status, and menopausal status. We randomized ER-negative, node-negative patients to 6 months of combination chemotherapy or to no treatment. Because of slow accrual, the study was closed and patients are now being entered onto a similar intergroup study with the Eastern Cooperative Oncology Group. We randomized ER-negative, node-positive patients to either 1 or 2 years of CMFVP.(ABSTRACT TRUNCATED AT 250 WORDS)

Forty-five patients with stage III M1 non-small cell bronchogenic carcinoma were treated with vinblastine (1 mg/m2 by iv bolus twice a day on 2 consecutive days) plus mitomycin (10 mg/m2 on Day 1). This treatment was repeated at 3-week intervals for three courses. Consolidation therapy with doxorubicin and cisplatin at doses of 50 mg/m2 each was administered to responders every 4 weeks for two courses, with subsequent vinblastine and mitomycin maintenance therapy every 6 weeks. Eleven partial remissions (24%) were achieved, with a median duration of remission of 16 weeks (range, 8-32) and a median survival of 19 weeks. No differences were seen in median duration of remission or survival by cell type or performance status.

Patients with advanced transitional cell bladder carcinoma were randomized to receive either adriamycin alone, or adriamycin plus DDP. Overall response (CR + PR) was 8/41 (19%) for adriamycin alone versus 16/37 (43%) for the combination (p = 0.02). Median response duration was 14 weeks for adriamycin versus 25 weeks for the combination (p = 0.17). Median survival was 28 weeks on adriamycin versus 31 weeks on the combination (p = 0.82). Median survival of responders was 43 weeks, and for patients with stable disease it was 29 weeks. This was significantly better than for those with increasing disease at 15 weeks (p = 0.02). Increased frequency of leukopenia and gastrointestinal toxicity were seen with the combination. Cardiotoxicity and nephrotoxicity were not prohibitive.