Quality assurance by specification and achievement of goals in palliative cancer treatment.

As the goals of palliative cancer treatments have not always been clearly specified, this paper describes how frequently the goals of palliative cancer treatment can be specified according to a given definition and how frequently those specified goals can be achieved. The clinical problems of 171 cancer patients were discussed in the Interdisciplinary Oncologic Conference (IOC) of the Cancer Centre University of Ulm (CCUU) and recommendations concerning further diagnostic treatments and/or therapy were provided. These recommendations had been documented and analysed retrospectively. The goals were classified as either cure or palliation or further investigation. If the goal was palliation, it was investigated whether or not the goal was specified as either alleviation of existing problems or prevention of impending problems. The achievement of the specified goals was assessed. Palliation was the goal of treatment in 119 (71%) of the 168 evaluable recommendations. In 83 of the 119 cases (70%), immediate treatment was recommended. The goal was specified in 57 (69%) of the 83 recommendations and could be realized in 24 of 57 specified cases (42%). Patients in this group survived longer (p < 0.01) than patients in whom the goals could not be achieved. Impending problems could be prevented more often (p = 0.001) in 14 out of 18 cases, while existing problems could be alleviated in only 10 out of 34 cases. It is concluded that specification of the goals of palliation is necessary because it is impossible to decide if a goal of treatment could be achieved or not unless the goal of treatment has been defined (as existing/impending problem). The prevention of impending problems could be investigated in prospectively controlled clinical trials.

Comparison of CA 15-3 and CEA in diagnosis and monitoring of breast cancer.

In order to assess the utility of the tumor-associated antigen CA15-3 in the diagnosis of breast cancer, this new tumor marker was measured pre-operatively in 1342 patients. This group comprised 509 patients with malignant disease (134 with breast cancer and 375 with other malignancies not involving the breast) and 833 patients with benign surgical diseases (95 patients with fibroadenoma of the breast, 738 with other benign diseases). The results were compared with those for carcino-embryonic antigen (CEA) in the diagnosis of breast cancer. CA15-3 was above the normal limits of 25 U/ml in 31% of the patients with breast cancer, in 22% of patients with other malignancies, and in 9% of patients with benign diseases. CEA was elevated in 26% of patients with breast cancer (greater than 3 ng/ml). CA15-3 levels were above 50 U/ml in 13% of the breast cancer patients, in 6% of patients with other malignancies, and in 0.2% of the patients with benign diseases. There was a good correlation between CA15-3 level and tumor stage in breast cancer. CA15-3 serum levels were over 50 U/ml in respectively 0%, 2%, 13%, and 73% of the patients with stages I, II, III, and IV. CA15-3 and CEA were also determined in 671 patients who had received initial curative surgery of breast cancer, and who regularly attended our follow-up clinic. CA15-3 was found to be more sensitive than CEA in detecting recurrences of breast cancer.(ABSTRACT TRUNCATED AT 250 WORDS)

Radiation treatment related factors influencing outcome in vulvar cancer patients.

The objective of this research is to identify the impact of radiation treatment factors on survival in vulvar cancer patients. We performed a follow-up study on 60 women with squamous cell carcinoma of the vulva treated at the Department of Radiotherapy of the University of Ulm from 1980 to 1997. The follow-up time ranged from 0.5 to 17 years (mean 6.5 years). The irradiated volume included vulva and regional lymph nodes. The influence of treatment factors (tumor resection versus no tumor resection, treatment time, dose) on overall and disease-free survival was examined. In addition, applied doses were corrected for treatment time using the extended alpha/beta-model for calculating the biologically effective doses. The applied dose was 48.1 +/- 13.2 Gy (median: 50 Gy). Treatment time was 40.4 +/- 19.4 days (median: 38 days). 34/60 patients underwent surgery with complete resection of macroscopic tumor. 26 of 60 patients were resected incompletely or only a biopsy was taken. In univariate analysis prognostic factors influencing overall and disease-free survival were, along with T- and N-stage, treatment time, and biologically effective dose. In multivariate analysis, biologically effective dose was the only significant factor. We conclude that biologically effective dose and treatment time are important treatment factors influencing overall and disease-free survival vulvar cancer patients.

[Arterial lesions following radiotherapy]. / Arterielle Gefässschäden nach Strahlentherapie.

From 1980 to 1990 twelve patients with vascular lesions attributable to irradiation were treated. The time interval between radiotherapy because of malignancy and onset of symptoms due to radiation-induced atherosclerosis was on an average 7 years (1 month-29 years). A typical morphological finding at angiography was the well-localised vascular lesion in the previous radiation area, its localisation clearly distinguishable from typical atherosclerotic lesions. 10 patients had other radiation damage with involvement of the skin and perivascular tissue frequently necessitating an extra-anatomic reconstruction (n = 6). 4 patients had an anatomical reconstruction, one had a PTA, one was treated conservatively. Due to absence of multifocal arteriosclerotic lesions, long-term results of vascular reconstruction are good and will certainly contribute to further improvement of life quality after curative therapy for malignant disease.

[Role of radiotherapy in malignant testicular tumors]. / Die Rolle der Strahlentherapie bei malignen Hodentumoren.

Early stages of seminoma are well treated by radiotherapy alone. In advanced stages modern combination chemotherapy allows to achieve improved results. In embryonal carcinomas and teratomas the management by radiotherapy is controversial. For the primary treatment of lymphomas of the testis, radiotherapy should be restricted to early stages.

[Pregnancy tests. Can we trust them?]. / Graviditetsprøver. Kan vi stole på dem?

PIP: The reliability of pregnancy tests, which detect the elevated level of chorionic gonadotropin (CG) in the urine of pregnant women, as well as the implications of positive and negative results, faulty readings, manufacturers' research guidelines, and public awareness are discussed. False positive results occur in 5/1000 tests and can result from (CG) being present in hydatidiform mole and choriocarcinoma; follicle-stimulating hormone (FSH) or luteinizing hormone (LH) can also trigger positive results. False negative readings can occur as a result of the low level of CG early in pregnancy, or from failure to test morning urine, which has the highest concentration of the hormone. A nomograph showing the number of false negative reactions as a function of phases of gestation takes into account the capacity of the test (100, 500, 1000 IE CG per liter urine), and can assure a much higher rate of accuracy. Another cause of false readings can be the presence of soap traces in the test tube -- this can be eliminated by the use of the slide test spiller. In 1982, about 355,000 tests were sold to the public, pharmacies, laboratories, and doctors. Public education by pharmacies can help assure a 95% reliability rate, especially if 1-2 weeks after the 1st test is taken, a 2nd one is done. These tests are reliable if taken at the right time, but only consultation with a doctor can assure certainty about pregnancy.^ieng

Multimodal therapy in rectal cancer.

The possibilities and results of multimodal treatment in rectal cancer were reviewed with respect to the results of surgical treatment only. Based on the results of 4 studies, reducing local relapse rates and increasing long-term survival rates significantly, postoperative radiochemotherapy (RCT) + chemotherapy (CT) should remain the recommended standard for R0 resected UICC II and III rectal cancers. Preoperative neoadjuvant radiotherapy (RT) reduced local relapse rates in 8 studies, and extended survival in one study that evaluated all eligible patients. Preoperative RT may evolve as standard, if the patient selection is improved and postoperative morbidity and long-term toxicity are reduced. Postoperative adjuvant RT reduced local relapses significantly in a single trial, and no impact on survival time is reported. Since postoperative RT is inferior to preoperative RT, this treatment cannot be recommended, if RT is chosen as a single treatment modality as an adjunct to surgery. Preoperative RCT + CT downstages resectable and nonresectable tumors and induces a higher sphincter preservation rate. This treatment may be routinely applied in nonresectable primary tumors or local relapses. Intraoperative RT could be added to this concept or be used together with preoperative/postoperative RT with the same indications. The results of local tumor excisions may be improved with pre- or postoperative RCT + CT.

Adjuvant radiochemotherapy--what is the patients benefit?

BACKGROUND: Local relapse is a major problem after potentially curative rectal cancer surgery. Although the incidence of local recurrences may be reduced by specialized surgical techniques such as total mesorectal excision (TME), local relapse rates of 20% or higher are the surgical reality today. Studies using adjuvant postoperative radiotherapy, chemotherapy, radiochemotherapy or immunotherapy have tried to reduce local relapse rates and distant progression. Postoperative radiochemotherapy has been the recommended standard, after complete resection of Union Internationale Contra la Cancrum (UICC) stages II and III rectal cancers. In view of recent positive results with preoperative radiotherapy of TME without adjuvant therapy, we found it important to review the literature to update the recommendable adjuvant procedure in rectal cancer. METHOD/PATIENTS: The literature from 1985 to May 1998 was reviewed for studies trying to either confirm or improve adjuvant therapy in rectal cancer. Only randomized controlled trials were analyzed with regard to their effectiveness in reducing the absolute rates of local recurrence and improving survival. RESULTS: Two trials applying adjuvant radiotherapy were able to demonstrate the reduction of local relapse rates, one trial with marginal significance, both without impact on survival. Four trials involving 1104 patients with rectal cancer stages UICC II-III compared postoperative radiochemotherapy with either surgical controls, adjuvant radiotherapy or conventional radiochemotherapy. In these trials, local relapse rates were significantly reduced by 11-18%, and survival rates significantly improved by 10-14%. Severe acute toxicities occurred in 50-61% of the patients, compromising compatibility, and caused death in 0-1%. Small-bowel obstruction leading to surgery was noted in 2-6% and to death in up to 2% of the patients. Intraoperative radiotherapy (IORT) improved local control and survival after surgery of locally advanced disease/local relapse. CONCLUSION: In view of four trials demonstrating a significant benefit of postoperative radiochemotherapy and with regard to recent still-debatable results of preoperative short-term radiotherapy optimal surgery with lowest local relapse rates plus postoperative radiochemotherapy remains the actual recommendable standard for rectal cancer surgery in R0 resected tumors stages UICC II+III.

Surgery, radio- and chemotherapy for multimodal treatment of rectal cancer.

The possibilities and results of multimodal treatment in rectal cancer were reviewed with respect to the results of surgical treatment only. Based on the results of 4 studies, reducing local relapse rates and increasing long term survival rates significantly, postoperative radiochemotherapy (RCT) + chemotherapy (CT) should remain the recommended standard for R0 resected UICC II and III rectal cancers. The addition of RT to adjuvant CT reduces local relapses without significant impact on survival (NSABP R-02). Vice versa, the addition of CT to RT or an improved CT in the RCT-concept prolongs survival. Preoperative neoadjuvant radiotherapy (RT) reduced local relapse rates in 9 studies, and extended survival in one study that evaluated all eligible patients. Preoperative RT reduced local relapse rates in addition to total mesorectal excision (TME) but did not extend survival. The preoperative RCT + CT downstages resectable and nonresectable tumors and induces a higher sphincter preservation rate. Phase III data justifying its routine use in all UICC II + III stages are not yet available. This treatment may be routinely applied in nonresectable primary tumors or local relapses. Preoperative RCT (or RT) may evolve as standard, if the patient selection is improved and postoperative morbidity and long term toxicity reduced. Intraoperative RT could be added to this concept or be used together with preoperative/postoperative RT at the same indications. Postoperative adjuvant RT reduced local relapses significantly in a single trial, and no impact on survival time is reported. Since postoperative RT is inferior to preoperative RT, this treatment cannot be recommended, if RT is chosen as a single treatment modality in adjunction to surgery. The results of local tumor excisions may be improved with pre- or postoperative RCT + CT. In the future, multimodal treatment of rectal cancer might be more effective, if individualized according to prognostic factors.