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A rectrospective analysis was performed of the results of 104 consecutive patients with carcinoma of the pyriform sinus, who underwent radiation therapy. Thirty-four patients underwent radical surgery and postoperative radiation therapy (group 1); 36 patients received radical radiation therapy alone (group 2); neoadjuvant chemotherapy was administered prior to full-dose radiation to 20 patients (group 3); 14 patients received palliative radiation therapy (group 4). Loco-regional control and survival rates at 5 years were 60.4% and 34.3% in group 1, 23.8% and 23.8% in group 2, 17.5% and 23.8% in group 3; no patients in group 4 survived at 5 years. Patients in group 1 experienced significantly better survival and local control than those in groups 2 and 3. No differences were observed between groups 2 and 3. Loco-regional recurrence was the main cause of failure in group 2 (69.4%) and 3 (70.0%). In group 1, 20.3% of cases developed distant metastases. Overall 5-year survival rate was 23.7%, confirming the poor prognosis of this disease. These results provide further support to the need of improving prevention and early diagnosis to improve both results and outcome in patients with carcinoma of the pyriform sinus.
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The aim of this randomised trial was to investigate the effect of induction chemotherapy before radiotherapy on survival in 302 patients with non-resectable squamous cell carcinoma of the lung. Radiotherapy, 56 Gy to the chest, was given to 154 patients and combined treatment, with chemotherapy preceding the radiotherapy, to 148 patients. Chemotherapy consisted of three courses of cisplatin (120 mg/m2) and etoposide (100 mg/m2 i.v. for 3 days) administered every fourth week. Median survival was 10.5 months in the radiotherapy arm and 11 months in the combined treatment arm. The 2-year survival rate was 17% in the radiotherapy arm and 21% in the combined treatment arm. Addition of chemotherapy seemed to significantly improve survival, according to the Cox multivariate analysis (P = 0.04), but as only a trend according to life-table analysis (P = 0.11). Chemotherapy also accomplished a trend towards improved local control (P = 0.08) and towards decreased metastatic disease (P = 0.10). 2 patients in the combined treatment arm, but none in the radiotherapy arm, died from toxicity. The conclusion was that the value of the chemotherapy used in this study was very modest, but the results strongly support further research for more efficient drugs and combinations.
BACKGROUND: Ductal carcinoma in situ (DCIS) of the breast is a disorder that has become more common since it may manifest as microcalcifications that can be detected by screening mammography. Since selected women with invasive cancer can be treated safely with breast conservation therapy it is paradoxical that total mastectomy has remained the standard treatment for DCIS. We did a randomised phase III clinical trial to investigate the role of radiotherapy after complete local excision of DCIS. METHODS: Between 1986 and 1996, women with clinically or mammographically detected DCIS measuring less than or equal to 5 cm were treated by complete local excision of the lesion and then randomly assigned to either no further treatment (n=503) or to radiotherapy (n=507; 50 Gy in 5 weeks to the whole breast). The median duration of follow-up was 4.25 years (maximum 12.0 years). All analyses were by intention to treat. FINDINGS: 500 patients were followed up in the no further treatment group and 502 in the radiotherapy group. In the no further treatment group 83 women had local recurrence (44 recurrences of DCIS, and 40 invasive breast cancer). In the radiotherapy group 53 women had local recurrences (29 recurrences of DCIS, and 24 invasive breast cancer). The 4-year local relapse-free was 84% in the group treated with local excision alone compared with 91% in the women treated by local excision plus radiotherapy (log rank p=0.005; hazard ratio 0.62). Similar reductions in the risk of invasive (40%, p=0.04) and non-invasive (35%, p=0.06) local recurrence were seen. CONCLUSIONS: Radiotherapy after local excision for DCIS, as compared with local excision alone, reduced the overall number of both invasive and non-invasive recurrences in the ipsilateral breast at a median follow-up of 4.25 years.
Tumors with low intrinsic radiosensitivity, low alpha/beta-ratios and, eventually, hypoxic tumors unable to undergo reoxygenation (because of intrinsic reasons or radiotherapy acceleration that delivers the total dose before the onset of reoxygenation) are likely to respond better to large fractions of radiotherapy. Accelerating the course of hypofractionated radiotherapy would further target tumors with high repopulation ability. Such hypofractionated and accelerated schedules are expected to confer unacceptable toxicity. Accordingly, we investigated the cytoprotective efficacy of amifostine as a potential key to permit the safe administration of such highly toxic regimens. Hypofractionated and accelerated radiotherapy with amifostine cytoprotection (HypoARC; 3.5 to 4 Gy/d x 12 days) was tested in phase I and II trials in patients with breast cancer. Early radiation skin toxicity was significantly lower, and late toxicity from breast, lung, muscle/bone structures, and nerves compared favorably with that associated with standard radiotherapy. The reduced overall treatment time (16 days v 44 days) renders HypoARC appealing, especially to older patients or patients residing some distance from radiotherapy centers. Molecular studies showed that HypoARC significantly improves local relapse-free survival in patients with highly proliferating tumors or tumors overexpressing proteins linked to increased resistance to radiation-induced apoptosis (ie, c-erbB-2 and mutant p53). Further clinical trials have been designed to test the safety and efficacy of HypoARC in other tumor types.
UNLABELLED: Uterine sarcoma is a poor prognosis disease, with a high risk of metastatic relapse. We conducted a study of adjuvant chemotherapy with cisplatin, ifosfamide, and doxorubicin followed by radiotherapy (n=18). The results were then compared in a matched case-controlled study to radiotherapy alone (n=16) or no therapy at all (n=2). Chemotherapy consisted in three cycles of adriamyein-platinum-ifosfamide (API) (doxorubicin 60 mg /m2 on day 1; cisplatin 100 mg /m2 on day 2; ifosfamide 5 g /m2 on day 1+mesna 5 g /m2 on day 1+granulocyte colony-stimulating factor; q 3 weeks). Drug doses were reduced (20% for ifosfamide and cisplatin) four times (four patients) due to hematologic toxicity. Compared to a case-control study of adjuvant radiotherapy alone, results were not decreased by the addition of a toxic chemotherapy. CONCLUSION: Adjuvant API chemotherapy followed by radiotherapy is a feasible protocol; a multicenter phase III study comparing radiotherapy alone versus API chemotherapy followed by radiotherapy just began in France.
BACKGROUND: The effect of adjuvant chemotherapy after resection of nonsmall cell lung cancer (NSCLC) remains an unresolved question. METHODS: From October, 1982, to November, 1986, 267 patients with resected NSCLC were included in a randomized trial. The adjuvant allocated treatments were either postoperative radiotherapy, 60 Gy in 6 weeks (radiotherapy group = 129 patients), or three courses of postoperative COPAC (cyclophosphamide, doxorubicin, cisplatin, vincristine, lomustine) chemotherapy followed by a similar radiotherapy schedule (chemotherapy/radiotherapy group = 138 patients). RESULTS: The sex ratio (M:F) was 19/1; mean age was 57 +/- 9 years. According to postoperative staging, 8 patients were Stage I, 70 were Stage II, and 189 were Stage III. The histologic type was squamous cell carcinoma in 175 patients, adenocarcinoma in 57, and large cell carcinoma in 35. The minimum follow-up was 6 years. Four patients were lost to follow-up. Death was recorded in 233 patients. No significant difference was observed in terms of disease free interval (P = 0.47, log-rank test), or overall survival (P = 0.68, log-rank test). With respect to the first site of relapse, distant metastasis occurred more frequently in the radiotherapy group (P = 0.09, log-rank test) whereas local relapse occurred similarly in both groups (P = 0.27). An interaction was observed between lymph node involvement and treatment in terms of overall survival. CONCLUSIONS: The COPAC chemotherapy as postoperative treatment failed to improve overall survival in patients with resected NSCLC receiving postoperative radiotherapy but decreased the pattern of metastatic progression, mainly in the N2 patients.
This cross-sectional study aimed to investigate the effect of supraclavicular fossa (SCF) radiotherapy volumes as well as patient characteristics and nodal pathology on the development of lymphoedema. Ninety-one women who had received SCF nodal radiotherapy after axillary dissection were evaluated. Lymphoedema was defined by two measurements: limb volume difference 200 mL, or circumference difference 10 cm proximal or distal to the olecranon>2 cm. On univariate analysis, the addition of axillary to SCF radiotherapy, increasing width of the SCF field, increasing age, presence of extracapsular extension of nodal involvement and use of hormone treatment was associated with lymphoedema by either one or both definitions. For both definitions of lymphoedema, on multivariate analysis, increasing nodal radiotherapy volume remained significant (P=0.02 to 0.007), as did increased age (P=0.05 to 0.001). We conclude that conventionally fractionated SCF radiotherapy limited laterally by the coracoid process has a lymphoedema risk similar to that expected from axillary dissection alone and a lower risk than wider SCF fields with or without an axillary boost.
The aim of preoperative radiotherapy of mastocarcinoma is to reduce the size of the tumor to enable radical surgery in the third stage. This method is preferable to postoperative radiotherapy for anatomical and radiobiological reasons. It has not yet been possible to prove beyond doubt that preoperative radiotherapy also has a favourable effect on symptom-free survival. Curative radiotherapy without mastectomy is recommended for tumors of 2 - 3 cm size which are mobile, in small and medium-sized breasts, if the axilla is free or has only 1 - 2 mobile lymphatic nodes. Tumorectomy must be followed by surgical revision of the axillary region. High-voltage equipment is mandotory for radiotherapy. Results obtained to date are in no way inferior to those of mastectomy. Local control rate is 90-100%. The cosmetic result is usually excellent.
Tumors of the base of skull represent a challenging radiooncological target due to their close proximity to dose limiting critical normal tissue structures. A critical review of the literature provides evidence that high-LET radiotherapy offers a therapeutic gain factor compared to low-LET radiation and should be the treatment of choice in advanced salivary gland malignancies, which are inoperable or not completely resected, and in recurrent disease. Modern techniques of conformal high LET radiotherapy, e.g. heavy ion beam radiotherapy, will help to reduce the long and the short term toxicity of radiotherapy.
Evaluation and radiotherapy implications of chest relapse patterns in small cell lung carcinoma treated with chemotherapy and radiotherapy to the chest and brain. Emphasis was placed on analysis of patterns of chest disease relapse, chest complications, and sites of initial chest disease relapse in relation to volume treated by radiation. These results were compared with published reports. Of 17 cases with disease limited to the chest (LD), nine (53%) died of chest related complications, seven of these (41%) with chest disease recurrence. However, in five of these seven cases (72%), recurrences appeared initially outside the irradiated volume, in spite of 1-2 cm of safety margin, mostly in the ipsilateral lung, while the primary was without evidence of growth. Hence, chest disease relapse does not necessarily mean radiotherapy failure, as only 2 of the 17 cases (12%) had definite tumor growth in the irradiated field. This point is not properly emphasized in the literature, where marked discrepancies among authors reporting chest disease relapses are present. We elaborate about factors that will affect results, like frequency of follow-up x-rays, tumor size, site of chest disease relapse, and criteria to define tumor relapse. More autopsy and chest diagnostic studies are needed to investigate patterns of tumor spread within the lung. Survival alone is too broad a factor to measure the impact of radiotherapy in treatment. We need more understanding of the mechanisms of chest disease relapse to obtain a better design of radiotherapy ports. Systemic disease was the main cause of death in 17 patients with extensive small cell lung carcinoma, and routine chest irradiation cannot be justified although it might be of help for chemotherapy responders who are expected to have long survival.
BACKGROUND: The timing of breast conserving surgery, chemotherapy, and radiotherapy in breast cancer treatment has become the subject of increasing interest over the last years. PATIENTS AND METHOD: Seventy-four patients who underwent postoperative radiotherapy at our institution between 1985 and 1992 form the basis of this study. Median follow-up time was 5 years. Seventy-three percent of patients were pre- or perimenopausal. Almost all patients (91%) were UICC-stage II. Axillary lymph nodes were positive in 95% of cases. Complete gross resection was achieved in all patients, and in 65% final pathological margins were free of invasive or intraductal carcinoma. Postoperatively, 70% of patients received 6 cycles of polychemotherapy (predominantly CMF) before onset of irradiation. The radiation dose was in almost all cases 60 Gy including 10 Gy boost. RESULTS: Five years after start of treatment overall survival, disease-free survival, and local recurrence rates were 86% (95%-confidence limits, 76 to 93%), 73% (61 to 83%), and 8% (3 to 16%), respectively. For disease-free survival, the only significant prognostic factor was the number of involved lymph nodes: 0 to 3 = 86%, > or = 4 = 40% (p < 0.0001). The interval between surgery and radiation (< or = versus > 20 weeks) had no significant influence on disease-free survival or local tumor control. In contrast, there was a trend of increased regional and distant failure with shortening of the interval due to the delivery of less than 6 cycles chemotherapy before the onset of radiotherapy. CONCLUSIONS: In our experience, there was no negative impact of a delay of radiotherapy in order to deliver full course chemotherapy before initiation of radiotherapy. However, the low statistical power of this analysis due to the small number of patients must be considered. it appears possible that a less intense chemotherapy before starting radiation treatment correlates with enhanced distant failure and subsequently decreased disease-free survival rates. Therefore, for patients at increased risk for distant metastasis, we prefer to give 6 cycles polychemotherapy before irradiation.
BACKGROUND AND PURPOSE: Growing incidence of cancer and the demographic changes of the society can cause severe shortage in radiotherapy services. This can lead to the use of waiting lists, which can serve as an indicator model for shortage of medical service. To investigate whether and how waiting lists are used in Germany, a survey was undertaken among German radio-oncologists. Their opinion concerning the use of waiting lists and their attitude toward the involved ethical problems were the central topics of this study. MATERIAL AND METHODS: A questionnaire was developed which consisted of 18 items: four items covered general aspects, four were about the management of waiting lists, seven concerned problems of waiting lists, and three were about the future aspects. From all items, at least ten touched ethical aspects such as patient information or the doctor-patient relationship. 19 consecutive radio-oncologists answered the questionnaire via telephone. The main interest of this study was to generate further hypotheses for future research. RESULTS: From all doctors (n = 19), most did not use waiting lists (n = 12) in their practice, whereas the remaining did use them (n = 7). Limited resources were seen as the central underlying problem (n = 16). Two guiding principles were most often quoted for managing waiting lists: patients with complaints such as pain before those without (n = 18) and curative before palliative radiotherapy (n = 15). Concerning the information given to patients about the use of waiting lists, some doctors voted for detailed information (n = 7), which covers negative side effects of waiting lists such as tumor progression during waiting time, others voted against (n = 11). There was a profound disagreement on the question of whether curative and palliative radiotherapy should be differently treated in the context of waiting lists. 70% of the group, who used waiting lists, could give a moral justification for waiting lists, whereas only 28% of the group, who did not use them, could offer a justification. CONCLUSION: The survey showed that doctors were most concerned about the ethical aspects of waiting lists. Open questions are: (1) What is the best principle for a fair distribution of limited radiotherapy places? (2) How should patients be informed about waiting lists? (3) What moral justifications can be given for waiting lists? These issues must therefore become topics of future research and national dialogue, because the answers to these questions are necessary for the clinical use of waiting lists in radiotherapy.
Extended surgical staging (ESS) has been added to total hysterectomy and bilateral salpingo-oophorectomy (TAHBSO) in patients with clinical Stage I endometrial cancer in order to better define patterns of metastatic spread and the response to treatment. Adjuvant radiotherapy has a demonstrated efficacy in decreasing central recurrence in Stage I disease. The combined use of radical surgery and pelvic radiotherapy for cervical cancer patients results in an increased incidence of complications. This study compares major complication rates in Stage I endometrial cancer patients who underwent either TAHBSO with ESS or TAHBSO alone followed by adjuvant external beam radiotherapy (RT). Records of 52 patients with clinical stage I endometrial cancer were reviewed. Thirty-two patients underwent TAHBSO plus ESS and 20 patients had TAHBSO alone. All patients received postoperative, whole pelvis external radiotherapy. Four patients suffered complications potentially related to treatment which required rehospitalization, and all 4 were in the group which had undergone ESS. A comparison of complication rates between the ESS + RT group (4/37 or 10.8%) and TAHBSO + RT group (0/20) suggested a trend toward significance (P less than 0.10). Treatment protocols using extended surgical staging prior to adjuvant radiotherapy in Stage I endometrial cancer should examine complications potentially related to this combination, to further define treatment risks and benefits.
PURPOSE: To compare the efficacy of concomitant irradiation with mitomycin C and bleomycin in patients with inoperable head and neck carcinoma with radiotherapy alone. METHODS AND MATERIALS: Between March 1991 and December 1993, 64 patients with inoperable head and neck carcinoma (41 with oropharyngeal site) were randomized to radiotherapy alone (group A) or radiotherapy combined with simultaneous application of mitomycin C and bleomycin (group B). In both groups patients were irradiated five times weekly with 2 Gy to a total dose of 66-70 Gy. The planned concomitant treatment in group B was: bleomycin 5 units twice a week i.m., total dose 70 units, mitomycin C 15 mg/m2 i.v. after delivery of 10 Gy, and 10 mg/m2 i.v. on the last day of radiotherapy. To enhance the effect of these two drugs, patients received also nicotinamide, chlorpromazine, and dicoumarol. Because significantly better results were achieved in arm B for patients with inoperable oropharyngeal carcinoma, the study was closed and such patients were after December 1993 routinely treated with the combined therapy (as in arm B). Until October 1996, we treated and followed up 48 such consecutive patients. RESULTS: Median follow-up of our study patients is 42 months. Complete remission (CR) rate in group A was 31% and in group B 59% (p = 0.04); disease-free survival (DFS) in group A was 8% and in group B 37% (P = 0.01); and overall survival (OS) was 7% in group A and 26% in group B (p = 0.08). CR rate for patients with oropharyngeal carcinoma was 29% in group A (N = 21) and 75% in group B (N = 20) (p = 0.007); DFS in group A was 10% and in group B 48% (p = 0.001); and the OS was 10% in group A and 38% in group B (p = 0.019). In patients with inoperable oropharyngeal carcinoma treated after December 1993, complete remission was achieved in 32/48 (67%, 95% CI: 52%-80%). DFS at the median follow-up of 14 months was 60% (95% CI 43-77%) and OS 58% (95% CI 42-74%). CONCLUSION: From the results of our study it seems that the concomitant treatment significantly improves CR rate, DFS, and OS in patients with inoperable oropharyngeal carcinoma in comparison with radiotherapy alone.
BACKGROUND: Phase II studies have shown primary (neo-adjuvant) chemotherapy with bleomycin, ifosfamide and cisplatin (BIP) is active against inoperable cervical cancer. We present here results of a randomised phase III multicentre trial comparing radical radiotherapy with neo-adjuvant BIP chemotherapy followed by radical radiotherapy in patients with inoperable cervical cancer, designed to discover whether this combination might improve survival. PATIENTS AND METHODS: Patients with inoperable cervical carcinoma were randomised to pelvic radiotherapy alone [RT] or two to three cycles of bleomycin 30 units/24-hour infusion, ifosfamide 5 g/m2/24 hours, and cisplatin 50 mg/m2) chemotherapy followed by pelvic radiotherapy (BIP + RT). Randomisation was stratified by stage and radiotherapy centre. RESULTS: One hundred seventy-two eligible women were randomised into this trial; eighty-six to RT and eighty-six to BIP + RT. A total of 190 cycles of chemotherapy were given. Median follow-up for the 47 patients still alive is 9 years with a minimum follow-up of 3 years. Complete or partial response occurred in 51 of 86 (59%) of those randomised to RT and 60 of 86 (69%) of those randomised to BIP + RT. The difference between response rates does not reach statistical significance (chi2 = 2.06, P = 0.15). Median survival is two years with an actuarial survival at five years of 32% (95% confidence interval (95% CI): 25%-39%). There is no significant difference between the treatment groups (chi2log-rank = 0.11, P = 0.74). CONCLUSIONS: This study does not show any survival benefit from the use of neo-adjuvant BIP chemotherapy in advanced cervical cancer.