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PubMed2003

Locoregionally advanced carcinoma of the oropharynx: conventional radiotherapy vs. accelerated hyperfractionated radiotherapy vs. concomitant radiotherapy and chemotherapy--a multicenter randomized trial.

PURPOSE: To compare conventional fractionation radiation therapy (RT), Arm A, vs. split-course accelerated hyperfractionated RT (S-AHF), Arm B, vs. conventional fractionation RT plus concomitant chemotherapy (CT), Arm C, in terms of survival and toxicity for advanced, unresectable epidermoid tumors of oropharynx. METHODS AND MATERIALS: Between January 1993 and June 1998, 192 previously untreated patients affected with Stage III and IV oropharyngeal carcinoma (excluding T1N1 and T2N1) were accrued in a multicenter, randomized Phase III trial (ORO 93-01). For Arms A and C, 66-70 Gy in 33-35 fractions, 5 days a week, were administered in 6.5-7 weeks to tumor and positive nodes. In Arm B, the dose delivered to tumor and involved nodes was 64-67.2 Gy, giving 2 fractions of 1.6 Gy every day with an interfraction interval of at least 4 h and preferably 6 h, 5 days a week. At 38.4 Gy, a 2-week split was planned; after the split, RT was resumed with the same modality. In Arm C, CT regimen consisted of carboplatin and 5-fluorouracil (CBDCA 75 mg/m(2), Days 1-4; 5-FU 1,000 mg/m(2) i.v. over 96 h, Days 1-4, recycling every 28 days (at 1st, 5th, and 9th week). RESULTS: No statistically significant difference was detected in overall survival (p = 0.129): 40% Arm A vs. 37% Arm B vs. 51% Arm C were alive at 24 months. Similarly, there was no statistically significant difference in terms of event-free survival (p = 0.196): 20% for Arm A, 19% for Arm B, and 37% for Arm C were event free at 24 months. On the contrary, the 2-year disease-free survival was significantly different among the three arms (p = 0.022), with a superiority for Arm C. At 24 months, the proportion of patients without relapse was 42% for Arm C vs. 23% for Arm A and 20% for Arm B. Patients in Arm A less frequently developed G3+ acute mucositis than their counterparts in Arm B or C (14.7% vs. 40.3% vs. 44%). Regarding the CT-related acute toxicity, apart from 1 case of fatal nephrotoxicity, only hematologic G3+ (Grade 3 or higher) acute sequelae were observed (World Health Organization scale), most commonly leukopenia (22.7%). Arm C showed slightly more G3+ skin, s.c. tissue, and mucosal late side effects (RTOG scale), although significant sequelae were relatively uncommon, and mucosal sequelae were most commonly transient. The occurrence of persistent G3 xerostomia was comparable in all three treatment arms. CONCLUSIONS: The combination of simultaneous CT and RT with the regimen of this trial is better than RT alone in advanced oropharyngeal squamous-cell carcinomas, by increasing disease-free survival. This improvement, however, did not translate into an overall survival improvement, and was associated with a higher incidence of acute morbidity.

Adult↗
PubMed1996

Chemotherapy plus radiotherapy compared with radiotherapy alone in the treatment of locally advanced, unresectable, non-small-cell lung cancer. A meta-analysis.

BACKGROUND: Survival of patients with locally advanced, unresectable (stage III), non-small-cell lung cancer treated with radiotherapy is poor. Trials of the addition of chemotherapy to radiotherapy have produced conflicting results. OBJECTIVE: To compare chemotherapy plus radiotherapy with radiotherapy alone in patients with stage III, non-small-cell lung cancer. DATA SOURCES: English-language journal articles published between 1987 and 1995 identified in a MEDLINE search. STUDY SELECTION: Randomized trials that reported survival after previously untreated patients received chemotherapy plus radiotherapy or radiotherapy alone were reviewed. DATA EXTRACTION: For all eligible articles, reported survival curves were used to determine the relative risk for death in each of 3 years. These data were combined to determine a pooled estimate of the relative risk for death at 1, 2, and 3 years. DATA SYNTHESIS: Fourteen articles reporting on a total of 2589 patients were reviewed. Compared with radiotherapy, the combination of chemotherapy and radiotherapy reduced the risk for death at 1 year (relative risk, 0.88 [95% Cl, 0.80 to 0.96]), 2 years (relative risk, 0.87 [Cl, 0.81 to 0.94]), and 3 years (relative risk, 0.83 [Cl, 0.77 to 0.90]). This corresponded to a mean gain in life expectancy of about 2 months. The magnitude of the treatment effect was similar when trials of concurrently and sequentially administered chemotherapy were considered separately. CONCLUSION: The addition of chemotherapy to radiotherapy improves survival in patients with locally advanced, unresectable, non-small-cell lung cancer. The absolute benefit is relatively small, however, and should be balanced against the increased toxicity associated with the addition of chemotherapy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1996

Epidermoid anal cancer: results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. UKCCCR Anal Cancer Trial Working Party. UK Co-ordinating Committee on Cancer Research.

BACKGROUND: Non-surgical management of anal cancer by radiotherapy alone or combined with chemotherapy has, in uncontrolled studies, yielded similar local tumour control and survival rates to surgery. However, whether the addition of chemotherapy improves outcome without adding to morbidity is not known. Our trial was designed to compare combined modality therapy (CMT) with radiotherapy alone in patients with epidermoid anal cancer. METHODS: From 856 patients considered for entry to our multicentre trial, 585 patients were randomised to receive initially either 45 Gy radiotherapy in twenty or twenty-five fractions over 4-5 weeks (290 patients) or the same regimen of radiotherapy combined with 5-fluorouracil (1000 mg/m2 for 4 days or 750 mg/m2 for 5 days) by continuous infusion during the first and the final weeks of radiotherapy and mitomycin (12 mg/m2) on day 1 of the first course (295 patients). We assessed clinical response 6 weeks after initial treatment: good responders were recommended for boost radiotherapy and poor responders for salvage surgery. The main endpoint was local-failure rate (> or = 6 weeks after initial treatment); secondary endpoints were overall and cause-specific survival. Analysis was by intention-to-treat. FINDINGS: In the radiotherapy and CMT arms, respectively, five and three were ineligible, and six and nine died 6 weeks after initial treatment. After a median follow-up of 42 months (interquartile range 28-62), 164 of 279 (59%) radiotherapy patients had a local failure compared with 101 of 283 (36%) CMT patients. This gave a 46% reduction in the risk of local failure in the patients receiving CMT (relative risk 0.54, 95% CI 0.42-0.69, p < 0.0001). The risk of death from anal cancer was also reduced in the CMT arm (0.71, 0.53-0.95, p = 0.02). There was no overall survival advantage (0.86, 0.67-1.11, p = 0.25). Early morbidity was significantly more frequent in the CMT arm (p = 0.03), but late morbidity occurred at similar rates. INTERPRETATION: Our trial shows that the standard treatment for most patients with epidermoid anal cancer should be a combination of radiotherapy and infused 5-fluorouracil and mitomycin, with surgery reserved for those who fall on this regimen.

Adult↗
PubMedDate not supplied

Radiotherapy and combined chemo-radiotherapy of rectal cancer.

During the last twenty years radiotherapy has been more frequently integrated with conventional demolitive surgery of rectal cancers because radical surgery, the treatment of choice of these tumors, has achieved a plateau of therapeutic results in the various stages of disease. The incidence of pelvic failures in stages B2 and C remains high, despite apparently complete resections. Disease-free interval, quality of life and survival are negatively affected. Radiotherapy at doses of about 50 Gy is able to destroy subclinical foci of disease after surgery (post-operative radiotherapy) or to reduce volume and infiltration of a locally extended tumor facilitating surgery (pre-operative radiotherapy). Moreover, radiotherapy proved to be effective in the treatment of pelvic recurrences. The great improvement of radiotherapeutic techniques in the last decade allows treatments at high doses to the target, minimizing the risk of side effects to contiguous normal tissues. A large number of clinical studies seems to demonstrate that the efficacy of radiotherapy is enhanced by combining chemotherapy both in the pre-operative approach and in the post-operative adjuvant treatment. To date, no definitive agreement about the optimal schedules of combined chemo-radiotherapy has been achieved. Many controlled studies are in progress investigating the most effective schedules with the minimal toxicity. The main indications of radiotherapy in the treatment of rectal cancer are here synthetically presented. Pros and cons of each approach are illustrated according to updated reports. For wider information on this topic of great interest and in progress the consultation of some reviews is suggested (1, 3, 23).

Chemotherapy, Adjuvant↗
PubMed1997

A phase III randomized trial comparing concurrent chemotherapy and radiotherapy with radiotherapy alone in resectable stage III and IV squamous cell head and neck cancer: preliminary results.

BACKGROUND: A phase III randomized comparison of radiotherapy alone versus combination chemotherapy and concurrent continuous-course radiotherapy was performed at the Cleveland Clinic Foundation. METHODS: Between March 1990 and June 1995, 100 patients with resectable stage III and IV squamous cell head and neck cancer were randomized to either Arm A: radiotherapy alone, 68-72 Gy at 1.8-2.0 Gy per day; or to Arm B: the identical radiotherapy with concurrent chemotherapy. Chemotherapy consisted of 5-fluorouracil, 1000 mg/m2/day, and cisplatin 20 mg/m2/ day, both given as continuous intravenous infusions over 4 days beginning on day 1 and day 22 of the radiotherapy. At 50-55 Gy, patients were clinically reassessed. If a response was evident, radiotherapy was completed. In non-responding patients, however, radiotherapy was terminated and surgery recommended. After completion of all treatment, salvage surgery was performed, if possible, for any residual primary or nodal disease or for any subsequent locoregional recurrence. RESULTS: Except for an overrepresentation of T1 patients on Arm A, the treatment arms were equivalent. Toxicity was greater in the patients on Arm B with a higher incidence of grade III and IV neutropenia, thrombocytopenia, cutaneous reaction, and mucositis. Feeding tubes were also required more often, and weight loss was greater on the chemotherapy arm. No toxic deaths occurred. With a median follow-up of 36 months, the Kaplan-Meier 3-year projections of relapse-free survival are 52% for Arm A and 67% for Arm B (p = .03), and the likelihood of developing hematogenous metastases is 21% for Arm A and 10% for Arm B (p = .04). Although overall survival is not significantly different, overall survival with successful primary site preservation was 35% for Arm A and 57% for Arm B (p = .02). This difference remains statistically significant in the subsets of patients with laryngeal and hypopharyngeal primaries but not in patients with oropharyngeal primaries. CONCLUSIONS: Continuous-course radiotherapy and concurrent combination chemotherapy is an intensive, toxic but tolerable treatment regimen, which, when compared with radio therapy alone, can produce an improvement in relapse-free survival, a decrease in distant metastases, and an improvement in overall survival with successful primary site preservation.

Antimetabolites, Antineoplastic↗
PubMed1984

Phase II randomized trial of radiotherapy alone vs the sequential use of chemotherapy and radiotherapy in stage III non-small cell lung cancer. Phase II trial of chemotherapy alone in stage IV non-small cell lung cancer.

In order to clarify if the sequential combination of chemotherapy and radiotherapy offered any advantage over radiotherapy alone in stage III non-small cell lung cancer, 33 patients were randomized between radiotherapy alone or chemotherapy followed by radiotherapy, then chemotherapy again. Chemotherapy consisted of a combination of cisplatinum, VP-16 and adriamycin. Twenty-four patients with stage IV disease received the same chemotherapy regimen alone for six cycles. Median survival for stage III patients receiving radiotherapy alone was 5 months. For patients receiving the sequential combination of chemotherapy and radiotherapy median survival was 11 months (log-rank test, P = 0.025). Median survival for stage IV patient receiving chemotherapy alone was 15 months. It is concluded that the sequential combination of chemotherapy and radiotherapy is significantly superior to radiotherapy alone in patients with stage III non-small cell lung cancer.

Adult↗
PubMed2005

Chemo-radiotherapy versus radiotherapy alone in the pre-operative treatment of resectable rectal cancer.

AIM: To determine the differences in downstaging, local control (LC), disease free survival (DFS) and overall survival (OS) between combined pre-operative chemoradiation and pre-operative radiotherapy alone in the treatment of resectable rectal cancer. METHODS: One hundred and ten patients who underwent pre-operative radiotherapy or chemo-radiotherapy were reviewed. Fifty-seven patients were treated with radiotherapy (30 Gy/3 Gy) alone and 53 patients with chemo-radiotherapy (bolus 5FU+45 Gy/1.8 Gy). The median interval between the end of neo-adjuvant treatment and surgery was 28 and 46 days for the patients treated with radiotherapy alone and chemo-radiotherapy. RESULTS: The groups were homogeneously distributed for all characteristics except for cN-stage with more clinically node positive patients in the combined modality treatment group (47 vs 73%). A significant downstaging for tumour and/or lymph node status was observed in both groups. More ypT0-x-is were observed after chemoradiation than after radiotherapy alone (26 vs 7%; p=0.02). The local control rate at 3 years was 94% for both groups. DFS after radiation and chemoradiation was comparable with a 3-year DFS of 83 and 88%, respectively. CONCLUSION: Both pre-operative schemes have similar outcomes concerning DFS, OS and LC. Tumour downstaging is associated with improved survival.

Adenocarcinoma↗
PubMed1997

Continuous hyperfractionated accelerated radiotherapy (CHART) versus conventional radiotherapy in non-small-cell lung cancer: a randomised multicentre trial. CHART Steering Committee.

BACKGROUND: Human tumour cells can proliferate rapidly, and giving radiotherapy in many small fractions may reduce long-term normal-tissue morbidity. In response to these observations, we developed the CHART (continuous hyperfractionated accelerated radiotherapy) regimen, which uses thirty-six small fractions of 1.5 Gy given three times per day, to give 54 Gy in only 12 consecutive days. We report the long-term follow-up of a trial of CHART versus conventional radiotherapy in patients with locally advanced non-small-cell lung cancer (NSCLC). METHODS: 563 patients were entered by thirteen centres between April, 1990, and March, 1995. We included patients with NSCLC localised to the chest with a performance status of 0 or 1 in whom radical radiotherapy was chosen as the definitive management. Patients were randomly allocated in a 3:2 ratio to CHART or conventional radiotherapy. The latter was thirty fractions of 2 Gy to a total dose of 60 Gy in 6 weeks. RESULTS: The groups were well matched for possible prognostic factors. Overall there was a 24% reduction in the relative risk of death, which is equivalent to an absolute improvement in 2-year survival of 9% from 20% to 29% (p = 0.004, 95% CI 0.63-0.92). Subgroup analyses (predefined) suggest that the largest benefit occurred in patients with squamous cell carcinomas (82% of the cases), in whom there was a 34% reduction in the relative risk of death (an absolute improvement at 2 years of 14% from 19% to 33%). During the first 3 months, severe dysphagia occurred more often in the CHART group than in the group on conventional radiotherapy (19 vs 3%). Otherwise, there were no important differences in short-term or long-term morbidity. INTERPRETATION: CHART compared with conventional radiotherapy gave a significant improvement in survival of patients with NSCLC. Further improvement may be achieved with dose escalation in conformal radiotherapy, by the addition of cytotoxic chemotherapy, and by hypoxic cell radiosensitisation.

Adult↗
PubMed2000

Palliative radiotherapy practice within Western European countries: impact of the radiotherapy financing system?

PURPOSE: To analyze the reimbursement modalities for radiotherapy in the different Western European countries, as well as to investigate if these differences have an impact on the palliative radiotherapy practice for bone metastases. MATERIALS AND METHODS: A questionnaire was sent to 565 radiotherapy centres included in the 1997 ESTRO directory. In this questionnaire the reimbursement strategy applied in the different centres was assessed, with respect to the use of a budget (departmental or hospital budget), case payment and/or fee-for-service reimbursement. The differences were analyzed according to country and to type and size of the radiotherapy centre. RESULTS: A total of 170 centres (86% of the responders) returned the questionnaire. Most frequent is budget reimbursement: some form of budget reimbursement is found in 69% of the centres, whereas 46% of the centres are partly reimbursed through fee-for-service and 35% through case payment. The larger the department, the more frequent the reimbursement through a budget or a case payment system and the less the importance of fee-for-service reimbursement (chi(2): P=0.0012; logit: P=0.0055). Whereas private centres are almost equally reimbursed by fee-for-service financing as by budget or case payment, radiotherapy departments in university hospitals receive the largest part of their financial resources through a budget or by case payment (83%) (chi(2): P=0.002; logit: P=0.0073). A correlation between the country and the radiotherapy reimbursement system was also demonstrated (P=0.002), radiotherapy centres in Spain, the Netherlands and the United Kingdom being almost entirely reimbursed through a budget and/or case payment and centres in Germany and Switzerland mostly through a fee-for-service system. In budget and case payment financing lower total number of fractions and lower total dose (chi(2): P=0.003; logit: P=0.0120) as well as less shielding blocks (chi(2): P=0.003; logit: P=0.0066) are used. A same tendency is found for the use of isodose calculations and field set-up, but without being statistically significant (P=0.264 and P=0.061 res.). The type of the centre and the reimbursement modality influence the fractionation regimen independently (P=0.0274). This is not the case for the centre size and the reimbursement, which were found to exert correlated effects on the fractionation schedule (P=0.1042). CONCLUSION: Reimbursement systems seem to influence radiotherapy practice. One should therefore aim to develop reimbursement criteria that pursue to deliver, not only the best qualitative, but also the most cost-effective treatments to the patients.

Bone Neoplasms↗
PubMed2001

Cyclophosphamide, doxorubicin, vincristine and prednisone chemotherapy and radiotherapy for stage I intermediate or high grade non-Hodgkin's lymphomas: results of a strategy that adapts radiotherapy dose to the response after chemotherapy.

BACKGROUND: A limited number cycles of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy followed by involved field radiotherapy is the treatment of choice for Ann Arbor stage I intermediate or high grade non-Hodgkin's lymphomas (NHL). The optimal radiotherapy dose in this combined modality setting, resulting in maximal disease control with minimal toxicity is unknown. In this retrospective single-center study we evaluated the results of a combined modality treatment strategy that adapts the radiotherapy dose to the response after chemotherapy, and focus on the influence of radiotherapy dose on local control and survival. PATIENTS AND METHODS: One hundred and forty patients with NHL Ann Arbor stages I/IE of intermediate or high grade malignancy received four cycles of CHOP chemotherapy followed by involved field radiotherapy (IF-RT). The radiotherapy dose for patients in complete response (CR) after CHOP was either 26 or 40 Gy. Patients in partial response (PR) after CHOP always received 40 Gy. The influence of the radiotherapy dose on treatment outcome was evaluated for patients in CR at the end of treatment (n=128). RESULTS: CR rates after chemotherapy and after radiotherapy were 67 and 91%, respectively. Seventy-four of the patients in CR after CHOP received 26 Gy, 20 patients in CR after CHOP 40 Gy. All patients in PR after CHOP (n=34) received 40 Gy. The localization of relapse (within or outside the radiation field) did not differ between patients receiving 26 or 40 Gy. Overall survival (OS) at 5 years for patients in CR after CHOP who received 26 and 40 Gy and for patients in PR after CHOP but CR after 40 Gy IF-RT was 76, 100 and 75%, respectively, (P=0.16), disease free survival (DFS) at 5 years 69, 90 and 75%, respectively, (P=0.52). CONCLUSIONS: No statistically significant differences in patterns of relapse or survival were found between patients receiving 26 or 40 Gy IF-RT, however the number of events in all subgroups was small.

Adult↗
PubMed2006

Long-term followup of a randomized study of locally advanced prostate cancer treated with combined orchiectomy and external radiotherapy versus radiotherapy alone.

PURPOSE: In a randomized study we compared the combination of orchiectomy and radiotherapy to radiotherapy alone as treatment for locally advanced prostate cancer. Patients who were treated only with radiotherapy initially underwent castration therapy at clinical progression, providing the opportunity to compare immediate vs deferred endocrine intervention. MATERIALS AND METHODS: In this prospective study 91 patients with locally advanced prostate cancer were randomized to receive external beam radiotherapy (46) or combined orchiectomy and radiotherapy (45) after surgical lymph node staging. Survival rates were calculated. RESULTS: During 14 to 19 years of followup 87% of the patients in the radiotherapy group and 76% in the combined orchiectomy and radiotherapy group died (log rank p = 0.03). Prostate cancer mortality was 57% and 36%, respectively (log rank p = 0.02). The difference in favor of combined treatment was mainly caused by lymph node positive tumors. For node negative tumors there was no significant difference in the survival rates. CONCLUSIONS: Immediate androgen deprivation should be considered instead of deferred endocrine treatment started at clinical progression for prostate cancer with spread to regional lymph nodes. While awaiting evidence from randomized trials, one should consider full dose radiotherapy for local control of locally advanced prostate cancer even when it is lymph node positive.

Adenocarcinoma↗
PubMed1998

Combined orchiectomy and external radiotherapy versus radiotherapy alone for nonmetastatic prostate cancer with or without pelvic lymph node involvement: a prospective randomized study.

PURPOSE: We compare the combination of orchiectomy and radiotherapy to radiotherapy alone as treatment for pelvic confined prostate cancer, that is T1-4, pN0-3, M0 (TNM classification). MATERIALS AND METHODS: In this prospective study 91 patients with clinically localized prostate cancer were, after surgical lymph node staging, randomized to receive definitive external beam radiotherapy (46) or combined orchiectomy and radiotherapy (45). Patients treated with radiotherapy alone had androgen ablation at clinical disease progression. The effects on progression-free, disease specific and overall survival rates were calculated. RESULTS: After a median followup of 9.3 years (range 6.0 to 11.4) clinical progression was seen in 61% of the radiotherapy only patients (group 1) and in 31% of the combined treatment patients (group 2) (p = 0.005). The mortality was 61 and 38% (p = 0.02), and cause specific mortality was 44 and 27%, respectively (p = 0.06), in groups 1 and 2. The differences in favor of combined treatment were mainly caused by lymph node positive tumors. For node negative tumors there was no significant difference in survival rates. CONCLUSIONS: The progression-free, disease specific and overall survival rates for patients with prostate cancer and pelvic lymph node involvement are significantly better after combined androgen ablation and radiotherapy than after radiotherapy alone. These results strongly suggest that early androgen deprivation is better than deferred endocrine treatment for these patients.

Adenocarcinoma↗
PubMed2006

Radiotherapy and sequential temozolomide compared with radiotherapy with concomitant and sequential temozolomide in the treatment of newly diagnosed glioblastoma multiforme.

Our objective was to determine and compare effects of sequential temozolomide vs. concomitant plus sequential temozolomide with conventional radiotherapy, in patients with newly diagnosed glioblastoma multiforme, comparing two independent trials. Sixty-four patients were treated on two consecutive separate phase II studies that used identical eligibility criteria and the same radiotherapy (60 Gy, 2 Gy/day, after surgery) and adjuvant temozolomide (200 mg/m/day for 5 days/28 days until progression), but differed in the absence or presence of a concomitant treatment with temozolomide (75 mg/m/day) during radiotherapy. In the first protocol (1999-2002), 21 patients (median age of 64 years) received radiotherapy alone and sequential temozolomide; in the succeeding protocol (2002-2004), 43 patients (median age of 61 years) with similar characteristics received radiotherapy with concomitant and sequential temozolomide. Median number of adjuvant cycles was five in both trials. Median survival was similar in both studies (18 vs. 17.4 months); overall survival rates at 6, 12, 18 and 24 months of all the population were 89, 69, 45 and 24%. No statistically significant differences were found among prognostic factors considered. Hematologic toxicities were mild and similar, with grade 3-4 neutropenia in 5-7% and grade 3-4 thrombocytopenia in 7-10% of patients in the sequential phases, and grade 3-4 thrombocytopenia in 7% in the concomitant phase of temozolomide. We confirmed that temozolomide combined with radiotherapy is well tolerated and provides a survival advantage compared with historical data using radiotherapy alone. Nevertheless, a concomitant use of temozolomide during radiotherapy does not seem to improve survival, although it does not increase toxicity.

Aged↗
PubMed1993

[Questions and aspects of radiotherapy of adult patients with localized supradiaphragmatic stage (CS I/II) Hodgkin's disease. 1. Questions and aspects on indications for primary and adjuvant radiotherapy].

Important studies of the therapy in patients with early stages of Hodgkin's disease aim at reducing the long-term risks, yet maintaining the high cure rate. Several prospective studies and two large meta-analyses did not observe a significant difference of the ten- or 15-year survival rate after radiotherapy or combined radio- and chemotherapy in the total group of patients with CS I/II A Hodgkin's disease, not withstanding a significant reduction of the recurrence risk after combined therapy. There is some evidence but no proof, that certain subgroups of patients with early stage, have a higher survival after combined therapy compared to that after radiotherapy alone. Most studies of therapy in Hodgkin's disease have a statistical power much too low, in order to demonstrate significant differences of the survival rate in the order of 10 to 15%. Randomized studies of chemo- versus radiotherapy in patients with PS I/II A and some PS III A have shown conflicting results. Patients with supradiaphragmatic Hodgkin's disease and CS I/II can be subdivided according to the recurrence risk after primary radiotherapy in the following subgroups: 1. Patients with a very low or a low recurrence risk of approximately 10 to 20%: patients less than 40 years old and CS I/II A NS/LP with less than three involved regions and no bulky mediastinal mass and an ESR below 30 mm. If there is only unilateral suprahyoidal lymph node involvement, primary radiotherapy of the involved region or a mini-mantle or a mantle field is acceptable and achieves a recurrence free survival of 90% or higher. If there is only non bulky mediastinal involvement, mantle field radiotherapy is acceptable and achieves a recurrence-free survival of at least 90%. In the other patients, primary irradiation of an extended mantle field without a staging laparotomy is an acceptable primary treatment, achieving a recurrence-free survival rate of approximately 80%. Another option is a staging laparotomy with splenectomy and a mantle radiotherapy for PS I/II. Few groups prefer primary chemotherapy alone or some type of a reduced chemotherapy with lesser toxicity combined with localized radiotherapy and long-term observations of a larger group of patients after the last type of treatment have to confirm the excellent early results. 2. Patients with an intermediate recurrence risk of approximately 20 to 40%: patients, who do not belong to group one or group 3.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1995

Results of a randomized comparison of radiotherapy and bromodeoxyuridine with radiotherapy alone for brain metastases: report of RTOG trial 89-05.

PURPOSE: To determine if the addition of bromodeoxyuridine (BrdUrd) to radiotherapy prolongs survival when compared to radiotherapy alone in patients with brain metastases. METHODS AND MATERIALS: Seventy-two patients with brain metastases were randomized to 37.5 Gy in 15 fractions of 2.5 Gy or to the same dose with BrdUrd 0.8 g/m2 per day for 4 days of each of 3 weeks. Drug treatment was begun on Thursday or Friday before the first week of radiotherapy. Patients had a Karnofsky performance score of at least 70, a neurological function classification of 1 or 2, and any primary tumor except central nervous system (CNS), leukemia, or lymphoma. The primary was absent, controlled, or under active radiotherapy. Patients were free of other metastases. They were stratified by primary site (breast, lung or other), number of metastases (single or multiple) and age (< 60 vs. > 60). RESULTS: There was no significant difference between the two treatment arms (p = 0.904). The study was open from October 1989 to March 1993 and accrued 72 patients. Only one patient in the RT only arm remains alive. The two treatment arms were balanced with respect to all stratification variables. Toxicity due to radiotherapy was similar in both arms. BrdUrd caused significant Grade 4 and 5 hematologic and skin toxicity in five patients. Two patients died due to hematologic toxicity and one from a Stevens-Johnson type skin reaction. Phenytoin played a role in the skin reactions and ranitidine was associated with the hematologic deaths. Ranitidine was eliminated, BrdUrd was discontinued after any hematologic toxicity, and no further Grade 4 or 5 toxicities were seen. The median survival was 6.12 months in the radiotherapy group and 4.3 in the BrdUrd group (p = 0.904). Patients with solitary brain metastases had significantly better survival (p = 0.031). CONCLUSIONS: BrdUrd did not enhance the efficacy of the radiotherapy regimen tested, in spite of the fact that brain metastases have shown high labeling indices. The toxicity of this schedule of BrdUrd administration was apparently increased by ranitidine and phenytoin.

Adult↗