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Biomedical subjects

L Goedhals

Publications and source records attributed to L Goedhals.

31 records · Page 2Linked to original sources
PubMed1994

Efficacy and safety profile of gemcitabine in non-small-cell lung cancer: a phase II study.

PURPOSE: The aim of this study was to evaluate the efficacy and toxicity of gemcitabine at higher doses than had been used previously in patients with non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Eighty-four patients (65 men, 19 women; age range, 35 to 75 years; mean age, 59 years) with locally advanced or metastatic pathologically documented NSCLC were enrolled. Patients had bidimensionally measurable disease, as defined by computed tomographic (CT) scan or chest x-ray. A total of 28.6% had previously been surgically treated, while 9.5% had received radiotherapy. Fifty-three patients commenced at a dose of 1,000 mg/m2, and 31 at a dose of 1,250 mg/m2. Patients were to receive two dose escalations of 25%, provided that overall toxicity was no worse than World Health Organization (WHO) grade 1 or WHO grade 0 for platelets. Responding patients were reviewed and validated by a blinded oncology review board (ORB) of experts not involved with the study. Of the original 84 patients enrolled, 76 were assessable. RESULTS: The overall response rate was 20% (95% confidence interval [CI], 11.6% to 30.8%). There were two complete responses (3%) and 13 partial responses (17%). Hematologic toxicity was negligible. WHO grade 3 WBC toxicity occurred in 0.9% of doses and WHO grade 4 in 0.1%. WHO grade 3 and 4 thrombocytopenia occurred in 0.1% and 0.1% of all doses, respectively. Nonhematologic toxicity was minor and easily controlled. Common side effects included peripheral edema, asthenia, and transient malaise. CONCLUSION: The single-agent efficacy of gemcitabine is equivalent to other agents commonly used to treat NSCLC. Gemcitabine has an unusually mild side effect profile for such an active agent. The nausea and vomiting experienced with gemcitabine are mild and generally well controlled with standard antiemetics; 5-HT3 receptor antagonists are typically not required. The use of gemcitabine does not cause significant alopecia, and hematologic toxicity is modest and unlikely to require hospitalization. Gemcitabine may have a role as monotherapy in patients with inoperable NSCLC.

Adult↗
PubMed1993

Peyronie's disease--a perspective on the disease and the long-term results of radiotherapy.

From 1966 to 1988, 98 of 108 patients with symptomatic Peyronie's disease received radiotherapy at our institution. In 11 of 61 patients (18%) who attended the clinic regularly for follow-up for longer than a year, new lesions distinct from the original lesions developed. This confirms that there is progression of the disease in a substantial number of cases after treatment. Long-term follow-up over an average of 111.5 months was achieved by means of a questionnaire in 47 of the 98 cases (48%). Forty-one of these patients (87.2%) had sexual intercourse after radiation. Twenty-eight of the 41 (68.3%) still have intercourse. Their average age at present is 59.6 years while the average age of the 13 patients (31.7%) not having intercourse is 70.9 years. The decline in sexual activity is thus age-related. Twenty-one of 25 patients (84%) experienced relief from pain, and angulation of the penis improved in 17 of 44 patients (38.6%) after radiotherapy. Radiotherapy may therefore be of benefit to patients with active Peyronie's disease and should be investigated in a randomised controlled study.

Adolescent↗
PubMed1992

Racial differences in patients with adenocarcinoma of the endometrium.

OBJECTIVE: To determine the differences between white and black women with regard to the presentation and behavior of adenocarcinoma of the endometrium. METHOD: Records of 273 (68%) white patients and 117 (32%) black patients with endometrial adenocarcinoma were reviewed in Bloemfontein, South Africa. Survival data was calculated according to the direct method where losses in follow-up were regarded as tumor deaths. RESULTS: Most patients (82%) were treated by pre-operative radium followed by total abdominal hysterectomy and bilateral salpingo-oophorectomy, with post-operative external irradiation where indicated. Pre-operatively, fewer black women had reached FIGO stage I, while a larger number had advanced to stages II-IV (P = 0.0024). In addition, the tumor differentiation was more often poor in the black group (P < 0.0001). Ten-year follow-up was achieved in 84% of the white patients and 51% of the black patients and the 10-year survival figures were 67% for white patients and 28% for blacks (P < 0.0001). CONCLUSION: Endometrial adenocarcinoma is a more aggressive disease in black women than it is in whites.

Adenocarcinoma↗
PubMed1988

Paget's disease of the breast.

Twenty patients with histologically proven Paget's disease of the breast are reviewed. They represent an incidence of 1.06% of all breast carcinomas seen over a 12-year period in the Bloemfontein academic hospitals. All cases had ductal carcinoma. Clinically, 20% presented with a mass only, 20% with nipple disease only and 60% with both lesions. More patients with a mass compared with patients with only nipple disease had positive axillary lymph nodes--68.7% v. 25%. Cumulative 5-year survival rates showed a 100% survival rate for patients with only nipple disease, and an 83% survival rate for stage I and II disease. All the patients with stage III and IV disease died within the 4-year follow-up period. Nipple (skin) involvement per se did not worsen the prognosis of patients presenting with both a mass and nipple disease. The main predictors of prognosis were tumour size and lymph node involvement. It is suggested that patients presenting with nipple involvement only and/or small T1 lesions close to the nipple could be treated with wide local excision and axillary dissection in discontinuity followed by radiotherapy to the rest of the breast.

Adult↗
PubMed1988

Malignant pleural mesothelioma: a disease unaffected by current therapeutic maneuvers.

From 1965 to 1985, 262 patients with malignant pleural mesothelioma were treated with cytostatics only; radiotherapy (RT); RT and cytostatics; or decortication plus RT plus cytostatics. The median survival (MS) from diagnosis was 9.6 months. This was similar for all comparable treatment groups. In a univariate analysis, significant favorable prognostic factors were good performance status (PS), duration of symptoms greater than 6 months at the time of diagnosis, early stage of disease, white race, and female sex. In a multivariate analysis, PS, race, duration of symptoms, and stage were of significance for a favorable prognosis. Age, pain as first symptom, histologic subtype, and RT dose were not of prognosis significance in this study. The stepwise addition of treatment modalities did not increase survival, which remained the same as that reported for untreated patients. Therefore, phase II trials of new agents offer the only hope for advance in the treatment of this disease.

Adult↗
PubMed1987

Complications in the treatment of Hodgkin's disease.

Early Hodgkin's disease is curable with radiotherapy, while combination chemotherapy is curative for stages III and IV. The acute side-effects of treatment (haematological, infectious and neurological toxicity), as well as the late side-effects (sterility, cardiac and pulmonary damage and secondary neoplasms), are therefore of major concern. Data on 60 patients treated over a 12-year period in Bloemfontein were analysed. The acute and chronic complications encountered were in the range expected and 6 patients developed secondary neoplasms. The possible reduction of these complications is discussed. It is concluded that the oncologist should select the best treatment consistent with a good chance of a durable remission but must weigh this against not only short-term but also long-term toxicity.

Adult↗
PubMed1984

[Palliative radiation schedules with and without chemotherapy in advanced carcinoma of the esophagus].

In a prospective randomized study, 272 patients with advanced oesophageal cancer were treated with radiation and bleomycin or vinblastine or a combination of both cytostatics. Two radiation schedules were tested, the one involving larger fractions in a shorter period of time. Evaluation of the treatment results showed that 67% of patients experienced significant relief of dysphagia. The median survival was 3 months and the 1-year survival 7%. No statistical difference in survival was noted among the different chemotherapy or radiation groups (level of significance 5%). It was concluded that monochemotherapy as given in this study made no difference in the treatment result. The larger radiation fraction and shorter treatment time schedule was as effective as the more conventional schedule and is the preferred treatment because of the shorter hospitalization period. A pharyngostomy tube proved effective in feeding the patients. Oesophageal cancer is a systemic disease and polychemotherapy will have to play a prominent part in a multimodality treatment approach if results are to improve.

Antineoplastic Combined Chemotherapy Protocols↗
PubMedDate not supplied

Optimization of the wedge filter parameters for a radiotherapy treatment planning system.

When a treatment planning system uses an empirical or semianalytical approach to describe the influence of a wedge filter on a photon beam, a number of experimentally determined parameters are required. These may be found from direct measurement. However, if the beam model is sensitive to the parameters, it will be necessary to optimize the parameter values to obtain better correspondence between dose profiles calculated by the model and actual measured profiles. The procedure is time consuming if optimization is done manually. We have developed an optimization scheme, using a personal computer, to find the set of wedge parameters which will result in the best fit of calculated wedge profiles (using the beam model of the treatment planning system) to measured wedge profiles. The procedure is efficient and calculated profiles were found to match measured profiles to within 2% of the central axis value.

Filtration↗
PubMedDate not supplied

Fadrozole versus megestrol acetate: a double-blind randomised trial in advanced breast cancer.

Ninety-six patients were entered into a randomised, double-blind, double-dummy, clinical trial to assess the efficacy and safety of fadrozole as compared to megestrol acetate as second-line hormonal treatment for patients with advanced breast cancer. Analysis of results was on an intention-to-treat basis and included response rate, time to progression (TTP), time to treatment failure (TTF) and survival. Forty-six patients received fadrozole and 50 were randomised to megestrol acetate. Patients and pretreatment prognostic variables were balanced in the two arms of the trial. The objective response rates [3/46 (7%) for fadrozole and 3/50 (6%) for megestrol acetate], TTP, TTF and survival were similar in the two arms of the trial. Toxicity was also similar in the two arms of the trial and consisted mainly of oedema, hypertension and minor gastrointestinal symptoms. Fadrozole appears to be as active as megestrol acetate in second-line hormonal treatment of advanced breast cancer.

Antineoplastic Agents, Hormonal↗
PubMedDate not supplied

Ondansetron compared with granisetron in the prophylaxis of cisplatin-induced acute emesis: a multicentre double-blind, randomised, parallel-group study. The Ondansetron and Granisetron Emesis Study Group.

This is the first international, multi-centre, double-blind, randomised, parallel group study to directly compare the efficacy and safety profile of a single intravenous dose of ondansetron (8 or 32 mg) with granisetron (3 mg) in the control of cisplatin-induced acute emesis. A total of 496 patients were randomised to receive one of three anti-emetic treatments prior to cisplatin chemotherapy (> or = 50 mg/m2). Of these, 165 and 162 patients received 8 and 32 mg of ondansetron, respectively, and 169 patients received 3 mg of granisetron. Complete control of emesis (0 emetic episodes) over 24 h was reported in 59% of patients in the 8-mg ondansetron group, 51% of patients in the 32-mg ondansetron group and 56% of patients in the granisetron group. Complete or major control (< or = 2 emetic episodes) was achieved in 76 and 74% of patients in the 8- and 32-mg ondansetron group, respectively, compared with 78% of patients in the granisetron group. Nausea graded none or mild 24 h after the start of cisplatin infusion was reported in 71 and 69% of patients in the 8- and 32-mg ondansetron groups, respectively, and in 73% of patients in the granisetron group. There were no significant differences between the treatment groups when global satisfaction scores were compared. Logistic regression models were fitted to assess any interaction between treatments and prognostic factors (age, gender, alcohol use, cisplatin dose or concomitant chemotherapy) on complete or major response, but there was no evidence of interaction for any factor. All three anti-emetic treatments were well tolerated and no severe or unexpected drug-related adverse events were observed with ondansetron or granisetron. Headache, the most reported drug-related adverse event for all three treatment groups, occurred in 9% of all patients. In summary, no significant difference was observed between any of the treatment groups with respect to emesis, nausea or drug-related adverse events.

Adult↗
PubMedDate not supplied

Ondansetron compared with granisetron in the prophylaxis of cyclophosphamide-induced emesis in out-patients: a multicentre, double-blind, double-dummy, randomised, parallel-group study. Emesis Study Group for Ondansetron and Granisetron in Breast Cancer Patients.

This is the first double-blind clinical trial in a homogenous group of patients to compare the recommended dosing schedules of ondansetron and granisetron in the control of prolonged emesis after cyclophosphamide-containing chemotherapy (48% CMF, 35% EC) for breast cancer. A total of 514 patients were recruited. Of the 488 patients included in the intent-to-treat analyses, 167 were randomised to group A [8 mg ondansetron intravenously (i.v.) + placebo by mouth (p.o.) before chemotherapy + 8 mg ondansetron p.o. twice daily (b.d.) until day 5], 155 to group B (placebo i,.v. + 8 mg ondansetron p.o. before chemotherapy + 8 mg ondansetron p.o. b.d. until day 5) and 166 to group C (3 mg granisetron i.v. + placebo p.o. before chemotherapy + placebo p.o. b.d. until day 5). On study day 1, the groups were comparable with respect to the proportion of patients experiencing up to 2 emetic episodes (group A: 89%; B: 86%; C: 91%) and in the severity of nausea (no nausea; group A: 51%; B: 55%; C: 54%). Over the 5-day study period significantly more patients were rescued or withdrawn due to lack of response after the granisetron regimen (26%) than after the i.v. + p.o. ondansetron regimen (11%; p < 0.001). Since there was no difference in these parameters on day 1, this reflects differences on days 2-5 and was also reflected in the all-oral ondansetron group over this period (group B: 12%; C: 22% on days 2-5). A significant difference in the severity of nausea after i.v. and p.o. ondansetron compared with granisetron was also observed over the 5-day study period (p = 0.009). This was reflected in a numerical difference in favour of the all-p.o. ondansetron regimen compared with the granisetron regimen (no nausea; group A: 33%; B: 34%; C: 25%). Again these differences reflected differences in nausea control on days 2-5, since no differences were observed on day 1. Logistic regression analyses adjusted for prognostic factors also revealed a significant difference (p = 0.011) in favour of the i.v. + ondansetron group compared with the granisetron group when complete plus major response was compared over days 2-5. No significant differences in the safety profiles of the three treatment groups were observed. There were no severe or unexpected drug-related adverse events and as is well established for the serotonin receptor antagonists, mild constipation (mean 8%) and mild headache (mean 8%) were most commonly reported.

Adult↗
PubMedDate not supplied

Ondansetron suppository: a randomised, double-blind, double-dummy, parallel-group comparison with oral ondansetron for the prevention of cyclophosphamide-induced emesis and nausea. The Ondansetron Suppository emesis study group.

This multinational, multicentre, randomised, parallel-group study compared the safety, tolerability and efficacy of ondansetron 8 mg orally twice a day with ondansetron suppository 16 mg once daily in patients receiving cyclophosphamide-containing chemotherapy. A total of 406 patients were randomised to receive ondansetron 8 mg p.o. (198 patients) or ondansetron suppository (208 patients) medication in a double-blind, double-dummy trial. The primary efficacy analysis revealed that ondansetron provided good anti-emetic control with 81% of patients in the 8 mg p.o. b.d. group and 73% of patients in the 16 mg ondansetron suppository o.d. group experiencing complete or major control of emesis (< or = 2 emetic episodes) on the worst day of days 1-3. The 90% confidence interval for the difference between the two treatments for complete or major control (1.4, 15.0%) showed that the treatments could be regarded as equivalent. A difference in favour of oral ondansetron treatment was noted for the complete control (0 emetic episodes) rates over days 1-3, but no differences were found on day 1. There were no significant differences in the distribution of nausea grades between the treatment groups on the worst day of days 1-3 or on day 1. The incidence of adverse events was similar for the two treatment groups, the most frequently reported events were headache and constipation. There were no significant laboratory findings in either treatment group. In conclusion this study showed that the ondansetron treatments could be regarded as equivalent for the primary efficacy endpoint and that ondansetron suppository was well tolerated and effective in the prevention of cyclophosphamide-induced emesis.

Administration, Oral↗