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T Le Chevalier

Publications and source records attributed to T Le Chevalier.

At least 91 records · Page 5Linked to original sources
PubMed1997

[Primary mediastinal non-seminomatous germ-cell tumors: from clinics to biology].

Primary mediastinal non-seminomatous germ-cell tumors (PMNSGCTs) are rare neoplasms that occur in young male adults. Incidence is evaluated about half that of extra-gonadal GCT. Their treatment is generally based on protocols used for testicular cancer, but with poorer results. Based on our experience of 40 patients with PMNSGCTs and data from the literature, we review here the clinical and biological data of these neoplasms. PMNSGCTs seem to constitute a specific entity, distinct from other GCT by the following criteria: true extra-gonadal origin, high incidence in patients with the Klinefelter's syndrome, over-representation of the yolk-sac component, poorer chemosensitivity and survival compared to other GCT, frequent occurrence of non-treatment related hematological neoplasia. The finding of an isochromosome of the short arm of the chromosome 12 in the leukemic karyotype is one of the strongest argument for a common origin in the yolk-sac component of the PMNSGCTs and their associated leukemia. Treatment of PMNSGCTs is still a challenge and should be conducted by a well-trained medical team.

Adolescent↗
PubMed1997

[New therapeutic strategies and current research in inoperable locally advanced non small-cell lung cancers (stage IIIB)].

Treatment of patients with inoperable locally advanced non small-cell lung cancer (NSCLC) remains disappointing with less of 5% of patients alive at 5 years. Both initial local control and circumvention of concomitant undetectable metastatic chemoresistant cells are the critical targets for the oncologists in charge of this disease. Results of a recent meta-analysis including 22 randomized studies comparing standard treatment (i.e. radiotherapy) to sequential chemoradiotherapy have undoubtabely well defined the role of cisplatine-containing chemotherapy in stage IIIB NSCLC, even if the 5 year survival benefit remains modest. However, high complete response rates and prolonged overall survival were observed with combinations of new promising chemotherapy regimens and new fractionated radiation schedules in several phase II studies. These results have to be corroborated by prospective randomized trials. Integration of more aggressive and more toxic strategies such as radical surgery in these initial inoperable locally advanced NSCLC are evaluating. Around these conventional therapies, the stage IIIB NSCLC represent a favoured target to elaborate innovative therapeutic approaches based on emergence of biotherapies as recombinant cytokines, antitumoral vaccine and gene therapy programs. The contribution of these new therapeutic options opens new directions in the therapeutic strategy and leads to hope a new promising era in the management and outcome of patients with these tumors.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1996

Phase I study of a recombinant adenovirus-mediated gene transfer in lung cancer patients.

BACKGROUND: Despite vigorous efforts at curbing tobacco consumption and aggressive combined-modality treatment programs, both the incidence of and the mortality from lung cancer have remained virtually unchanged in the last 10 years. More effective innovative therapies are clearly needed. The direct transfer into tumor cells of tumor suppressor genes or toxic gene products that specifically promote tumor cell death and spare nonmalignant cells is a potentially novel anticancer treatment approach that should be investigated. PURPOSE: On the basis of compelling preclinical data, we initiated a phase I study involving six patients with inoperable lung cancer and an endobronchial lesion accessible by bronchoscopy. Our purpose was to evaluate the feasibility, tolerance, and clinical, biologic, and immunologic effects of the intratumoral administration of a recombinant, replication-deficient adenovirus (rAd.RSV beta-gal), using the Rous sarcoma virus promoter to drive transcription of the Escherichia coli lacZ marker gene that encodes for the bacterial enzyme beta-galactosidase (beta-gal). METHODS: From June 1994 through April 1995, six patients (five males and one female) were enrolled in the trial. A single dose of recombinant virus suspension containing 10(7) or 10(8) plaque-forming units (PFU) was injected intratumorally into two successive cohorts of three patients. Eligible patients received concomitant chemotherapy. Patients were kept under isolation conditions from 3 days before the injection was given until virus excretion was undetectable. Biopsy specimens of the tumor and surrounding mucosa were collected on the 8th day and at 1, 2, and 3 months after injection. They were analyzed by cell culture, polymerase chain reaction (PCR), and beta-gal expression for the presence of recombinant adenovirus. So that the risk of virus recombination or complementation could be minimized, wildtype adenovirus carriers among the hospital staff (identified by PCR) were excluded from contact with patients who were potentially excreting recombinant virus. RESULTS: beta-gal was expressed in tumor biopsy specimens of three patients (one who received the 10(7) PFU dose level and two who received 10(8)). Bronchoalveolar lavage specimens collected immediately after injection were positive for recombinant adenovirus when analyzed in culture and by PCR. All biologic fluids were negative for recombinant virus as judged by PCR after day 12, with the exception of bronchoalveolar lavage specimens (positive PCR up to 90 days in two of three patients treated with 10(8) PFU). The blood samples obtained from the three patients treated with 10(8) PFU showed positive PCR results immediately after virus injection. Patients were kept in isolation for a median of 17 days. The most common toxic effects were moderate bleeding (occurring in two patients) during bronchoscopy and fever (seen in four patients). Endoscopic and clinically objective antitumor responses were seen in four patients, including one patient who showed a complete response by pathologic evaluation. The median survival for the patients was 12.5 months (range, 3-16+ months). Throughout the study, hospital staff remained negative for recombinant adenovirus infection. CONCLUSIONS: This ongoing phase I study has demonstrated that a recombinant adenovirus-mediated marker gene, such as rAd.RSV beta-gal, can be safely introduced into humans and that the gene product is expressed by lung tumor cells of the host.

Adenoviridae↗
PubMed1996

[Chemotherapy of non-small-cell lung cancers].

Lung cancer is the major cause of cancer-related death in France among men and its incidence is increasing in women. Approximately 80% of lung cancers are of the "non-small cell" subtype (NSCLC) and surgery is the only curative treatment of this disease. Nevertheless, about 90% of patients will require a systemic treatment, either because of local invasion or a distant dissemination. Traditionally, NSCLC was considered to be a chemoresistant tumor and the role of chemotherapy was largely discussed. A recent meta-analysis on the role of chemotherapy in NSCLC included more than 9,000 patients: it demonstrated that cisplatin-based combinations provide a significant survival benefit in patients with inoperable NSCLC. New drugs such as vinorelbine, camptothecins, taxoids and gemcitabine are now available and can be used as single agents or in combination. Their activity should provide an increasing response-rate and a survival improvement in patients with metastatic disease. The combination of chemotherapy with radiation therapy and/or surgery also should increase both the complete response rate and cure rate in patients with limited disease.

Antineoplastic Agents↗
PubMed1996

Concurrent cisplatin-vindesine and hyperfractionated thoracic radiotherapy in locally advanced nonsmall cell lung cancer.

PURPOSE: Local failure is a major problem in locally advanced nonsmall cell lung cancer. The main objective of this Phase II trial was to test the feasibility of a combined concurrent radiotherapy and chemotherapy approach in an attempt to improve local control. METHODS AND MATERIALS: From December 1989 to December 1992, 34 patients were included. The treatment schedule consisted of hyperfractionated radiotherapy (60 Gy in 48 fractions and 6 weeks with two daily sessions of 1.25 Gy), cisplatin (6 mg/m2 every day of radiotherapy), and vindesine (2.5 mg/m2 once weekly). After a 3-week rest period, two full cycles of cisplatin (120 mg/m2 on weeks 10 and 14) and vindesine (2.5 mg/m2 on weeks 11, 12, and 13) were given. Treatment evaluation with thoracic computed scan, bronchoscopy, and bronchial biopsies was performed 3 months after completion of radiation therapy. Failure rates were estimated using a competing risk approach. RESULTS: The complete response rate was 50%. Local failure rates at 1 and 3 years were 53 and 56%, respectively. Distant metastases rates at 1 and 3 years were 26.5 and 29%. Overall survival rates at 1, 2, and 3 years were respectively 53, 33, and 12%. Severe esophagitis was observed in three patients (9%). Lethal toxicity was observed in two patients. CONCLUSION: This Phase II trial confirms the feasibility of this type of approach with specific dose reduction and suggests that it may improve local control compared to conventional approaches.

Adult↗
PubMed1996

Activity of gemcitabine in patients with non-small cell lung cancer: a multicentre, extended phase II study.

Gemcitabine is a novel nucleoside analogue with activity in solid tumours. This study assessed the objective response rate to gemcitabine given weekly intravenously at a dose of 1250 mg/m2 for 3 weeks followed by 1 week of rest (one cycle) in chemonaive patients with inoperable non-small cell lung cancer (NSCLC). 161 patients with NSCLC were recruited from 10 sites in nine countries. Most patients had stage IIIb (31.3%) or IV (64.6%) disease, and 93.8% had a performance status of 0 or 1 according to the WHO scale. Of 151 evaluable patients, there were 3 complete responses and 30 partial responses lasting at least 4 weeks for an objective response rate of 21.8% (95% CI 15.5-29.3%). All responses were validated by an extramural Oncology Review Board. The mean duration of response was 8.8 months. The mean survival for all patients (16.1% of patients still alive 26 months after last patient started treatment) was 11.5 months. Improvements were also observed in secondary efficacy parameters such as performance status, weight, analgesic requirement, pain, and other disease-related symptoms including cough, dyspnoea, haemoptysis, anorexia, somnolence and hoarseness. Haematological and non-haematological toxicity was mild given the biological activity of gemcitabine. This study confirms gemcitabine as one of the most active agents in NSCLC with the added benefit of a modest toxicity profile and ease of administration on an out-patient basis. Gemcitabine is a suitable candidate for combination chemotherapy in patients with NSCLC.

Adolescent↗
PubMed1996

The cost-effectiveness of navelbine alone or in combination with cisplatin in comparison to other chemotherapy regimens and best supportive care in stage IV non-small cell lung cancer.

An economic evaluation was undertaken, using data from European and Canadian randomised controlled trials of chemotherapy in advanced non-small cell lung cancer (NSCLC), to determine the cost and cost-effectiveness of single-agent vinorelbine (Navelbine, NVB) therapy and NVB in combination with cisplatin (NVB-P) compared to vindesine in combination with cisplatin (VDS-P), standard regimens including VP-16-cisplatin (VP-16-P) and vinblastine-cisplatin (VLB-P) and best supportive care (BSC). The Population Health Model (POHEM) developed by Statistics Canada was used to model the cost of care per patient, the total burden of cost to the Canadian healthcare system and the cost-effectiveness of the therapeutic interventions relative to BSC and to standard chemotherapy regimens, expressed as the cost per life year gained (LYG). Based on this analysis, VLB-P proved to be the most cost-effective chemotherapy regimen relative to BSC, as it increased average survival by 0.27 years while reducing costs by $3265 per case. NVB-P increased survival to a greater degree (0.44 years/patient) while inpatient administration increased costs by $2451 per case, for a cost-effectiveness ratio of $5551 per LYG. Outpatient administration, which reduced the cost of care per case by $473, was shown in the model to be the most cost-effective way to administer this regimen. Relative to VP-16-P and VLB-P, outpatient NVB-P regimen proved to be cost-effective at $7902 and $16404 per LYG, respectively. Based on our estimates, a variety of chemotherapy regimens, including outpatient NVB-P, are cost-effective in the management of advanced (Stage IV) NSCLC and competitive with some commonly used healthcare interventions. Therefore, cost and cost-effectiveness should not be barriers to the utilisation of NVB-P therapy in Canada.

Antineoplastic Agents, Phytogenic↗
PubMed1996

Combined systemic chemoimmunotherapy in advanced diffuse malignant mesothelioma. Report of a phase I-II study of weekly cisplatin/interferon alfa-2a.

PURPOSE: To assess the tolerance, toxicity, and antitumoral activity of the weekly combination of cisplatin (CDDP) and interferon alfa-2a (IFNalpha2a) in advanced diffuse malignant mesothelioma (DMM). PATIENTS AND METHODS: Twenty-six patients with DMM (23 pleural and three peritoneal), previously untreated, were enrolled onto this study between August 1991 and December 1992. All patients had measurable disease defined by computed tomographic (CT) scan and diagnostic confirmation by histopathology review panel. IFNalpha2a (3 x 10(6) IU subcutaneously on days 1 to 4) and CDDP (60 mg/m2/wk on day 2) were given weekly. Initially planned as a 5-weeks-on/3-weeks-off treatment cycle, poor patient tolerance observed in the first 12 patients treated (group A) led to schedule adaptation with a shorter treatment sequence and prolongation of the rest period (4 weeks on/4 weeks off) in the following 14 patients (group B). At least two cycles were administered to each patient in the absence of tumor progression. RESULTS: Twenty-six patients were assessable for toxicity and 25 for efficacy (World Health Organization [WHO] criteria). Sixty-eight cycles of IFN/CDDP were given, with a median of three cycles per patient (range, one to five). Toxicity was mainly clinical, with progressive anorexia, asthenia, and prolonged nausea/emesis; these side effects have limited treatment acceptance in many patients. Thrombocytopenia and leukopenia were rarely noted as treatment-limiting toxicities. Objective responses (all partial) were obtained in 10 patients (95% confidence interval [CI], 20% to 60%). The median response duration was 11 months (range, 6 to 18). The median time to progression (TTP) for the whole cohort was 6 months and the median survival time was 12 months (range, 5 to 32). Objective responders had a significantly longer median TTP (21 months) and survival time (25 months) than nonresponders (3 and 8 months, respectively). CONCLUSION: The results of this pilot phase I-II study show encouraging antitumor activity in this traditionally resistant tumor, even if the specific contribution of IFN remains speculative and needs further clinical research. Our ongoing program is exploring the dose-intensity impact of IFN dose within the same combination.

Adult↗
PubMed1996

Surgery for lung metastases from colorectal cancer: analysis of prognostic factors.

PURPOSE: To identify prognostic factors of improved survival after resection of isolated pulmonary metastases (PM) from colorectal cancer. PATIENTS AND METHODS: A retrospective analysis of the records of all patients with PM from colorectal cancer who underwent thoracic surgery with curative intent before December 1992 at a single surgical center was performed. Univariate (log-rank) and multivariate (Cox's model) analyses of survival were used to identify significant prognostic factors. RESULTS: Eighty-six patients with PM from colon (n = 49) or rectal (n = 37) cancer underwent 102 thoracic operations, which included 21 bilateral and 10 incomplete resections. The 5- and 10-year probabilities of survival (Kaplan-Meier) after the first thoracic operation were 24% (95% confidence interval [CI], 15% to 35%) and 20% (95% CI, 13% to 31%), respectively. Sex, age, site of the primary tumor (colon or rectum), disease-free interval (DFI), and previous resection of hepatic metastases were found not to be statistically significant prognostic factors. Complete resection, a limited number ( < two) of PM, and a normal prethoracotomy serum carcinoembryonic antigen (CEA) level were predictors of a longer survival duration by univariate analysis, but only complete resection (P = .024) and preoperative CEA level (P = .001) were identified as independent prognostic factors by multivariate analysis. The estimated 5-year survival rate of patients with a normal prethoracotomy CEA level was 60%, as compared with 4% in cases with elevated ( > 5 ng/mL) CEA level. CONCLUSION: Besides resectability, the prethoracotomy serum CEA level appears the most reliable predictor of survival in patients with isolated PM from colorectal cancer.

Adenocarcinoma↗
PubMed1996

[Results of a randomized study comparing combination of navelbine-cisplatin to combination of vindesine-cisplatin and to navelbine alone in 612 patients with inoperable non-small cell lung cancer].

The combination of vindesine and cisplatin is considered a reference regimen in advanced NSCLC which has yielded a significant improvement in the duration of survival. A phase II study of a new semi-synthetic vinca alkaloid, Navelbine, reported an unusually high 29% response rate in stage III-IV NSCLC and a phase I-II study established the feasibility of the combination of Navelbine and cisplatin. We, therefore, designed a prospective randomized trial to compare Navelbine and cisplatin (NVB-P) to vindesine and cisplatin (VDS-P) and to evaluate whether the best of these regimens affords a survival benefit compared to Navelbine alone (NVB), an outpatient regimen. Forty-five centers included 612 patients in this study: 206 in NVB-P, 200 in VDS-P and 206 in NVB. Navelbine was given at a dose of 30 mg/m2 weekly, cisplatin at 120 mg/m2 on day 1, day 29 and then every 6 weeks and vindesine at 3 mg/m2 weekly for 6 weeks and then every other week. Treatment was continued until progression or toxicity. Patients' characteristics were similar in the three groups with 59% of patients presenting with metastatic disease. An objective response rate was observed in 30% of patients in NVB-P versus 19% in VDS-P (P = .02) and 14% in NVB (P < .001). The median duration of survival was 40 weeks in NVB-P compared to 32 weeks in VDS-P and 31 weeks in NVB. The comparison of survival between the three groups demonstrated an advantage for NVB-P compared to VDS-P (P = .04) and NVB (P = .02). Neutropenia was significantly higher in the NVB-P group (P < .001) and neurotoxicity more frequent with VDS-P (P < .004). Since our results have demonstrated that NVB-P yields a longer survival duration and a higher response rate than VDS-P or NVB alone, with acceptable toxicity, this combination should be considered a reference regimen in advanced NSCLC.

Adult↗
PubMed1996

[Inappropriate antidiuretic hormone secretion disclosing a second primary lung cancer 5 years after complete remission of a small cell lung carcinoma].

We report the case of a female patient who developed a second contralateral small cell lung carcinoma (SCLC) five years after a right upper lobe SCLC treated by sequential chemotherapy and chest radiation therapy. This second primary neoplasia was revealed by an isolated and symptomatic syndrome of inappropriate antidiuretic hormone secretion. Specific evolution of long-term survivors after SCLC are discussed, including consequences of combined radiochemotherapy and poor prognosis associated with persistence of tobacco smoking exposure.

Carcinoma, Small Cell↗
PubMed1996

Single-agent activity of gemcitabine in advanced non-small cell lung cancer.

Gemcitabine, a novel nucleoside analog, shows reproducible response rates of 20% and above in single-agent studies in non-small cell lung cancer. In the phase II studies reported, chemotherapy-naive patients received gemcitabine (starting doses, 800 to 1,250 mg/ m2) as a single agent on days 1, 8, and 15 of a 28-day cycle. In three large studies of 82, 84, and 161 patients, response rates were 22.5%, 20%, and 21.8%, respectively. The median duration of response in these studies was 8.1, 12.7, and 7.6 months, respectively. The median length of survival for all patients (responders and non-responders) was 8.1, 9.2, and 9.4 months, respectively. Three trials in Japan involving 206 patients produced response rates of 16.3%, 26.0%, and 20.9%. A US phase I/II study of gemcitabine at doses of 1,000 to 2,800 mg/ m2 recorded an overall response rate of 26% in a population of mainly stage IV (87%) patients. Responses were seen across disease stages and histologic subtypes in performance status 0, 1, and 2 patients and in the elderly. Gemcitabine produced marked benefit (lasting 2 to 5 months) in a number of disease-related symptoms, most notably cough, hemoptysis, and dyspnea. Improvements in performance status were seen in 52% of patients receiving gemcitabine. Gemcitabine was well tolerated with few of the side effects normally associated with cytotoxic drugs.

Adult↗
PubMed1995

Pattern of failure in patients with inflammatory breast cancer treated by alternating radiotherapy and chemotherapy.

BACKGROUND: Patients with inflammatory breast cancer have a high risk of developing a local recurrence and/or distant metastases. Treatment with combined chemotherapy and locoregional radiotherapy contributes to a decrease in both risks. This study presents treatment results and evaluates the pattern of failure when an alternating chemoradiotherapy schedule is used. METHODS: One hundred twenty-five patients with nonmetastatic inflammatory breast cancer were treated with an alternating schedule of radiotherapy and chemotherapy. All women recruited were younger than 70 years of age and had a T4d, histologically proven infiltrating carcinoma with N0 to N2 axillary disease. The protocol consisted of three cycles of induction chemotherapy with doxorubicin, vincristine, cyclophosphamide, methotrexate, and 5-fluorouracil followed by three series of locoregional radiotherapy, delivering a total dose of 65-75 Gy to the breast tumor. Five additional cycles of chemotherapy with 5-fluorouracil/doxorubicin/cyclophosphamide were to be administered in between the first two and after the third radiotherapy course. A 1-week gap was respected between each course of chemotherapy and each series of radiotherapy. RESULTS: Toxicity was moderate and this strategy proved feasible although most of the patients only received six instead of the eight planned cycles of chemotherapy. Eighty-two percent of the patients achieved a complete response at the end of the treatment. The cumulative 5-year local failure and distant metastasis rates were 27% and 53%, respectively. Assuming competing events, local failures, contralateral recurrences, and distant metastases were the first site of failure in 18%, 5%, and 38% of patients, respectively. The 5-year overall and disease free survival rates were 50% and 38%, respectively. The main prognostic factor was tumor size. CONCLUSIONS: Alternating high doses of radiotherapy and chemotherapy is a feasible treatment schedule and permits breast conservation. Disease free survival is comparable to that of recently published series. As the main causes of failure are distant metastases, higher dose chemotherapy should be evaluated, in an attempt to further improve overall survival.

Adenocarcinoma↗
PubMed1995

Adjuvant radiotherapy versus combined sequential chemotherapy followed by radiotherapy in the treatment of resected nonsmall cell lung carcinoma. A randomized trial of 267 patients. GETCB (Groupe d'Etude et de Traitement des Cancers Bronchiques).

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.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1995

Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission.

BACKGROUND: Prophylactic cranial irradiation in patients with small-cell lung cancer decreases the overall rate of brain metastases without an effect on overall survival. It has been suggested that this treatment may increase neuropsychological syndromes and brain abnormalities indicated by computed tomography scans. However, other retrospective data suggested a beneficial effect on overall survival for patients in complete remission. PURPOSE: Our purpose was to evaluate the effects of prophylactic cranial irradiation on brain metastasis, overall survival, and late-occurring toxic effects in patients with small-cell lung cancer in complete remission. METHODS: We conducted a prospective study of 300 patients who had small-cell lung cancer that was in complete remission. The patients were randomly assigned to receive either prophylactic cranial irradiation delivering 24 Gy in eight fractions during 12 days (treatment group) or no prophylactic cranial irradiation (control group). A neuropsychological examination and a computed tomography scan of the brain were performed at the time of random assignment and repeatedly assessed at 6, 18, 30, and 48 months. Patterns of failure were analyzed according to total event rates and also according to an isolated first site of relapse, using a competing-risk approach. RESULTS: Two hundred ninety-four patients who did not have brain metastases at the time of random assignment were analyzed. The 2-year cumulative rate of brain metastasis as an isolated first site of relapse was 45% in the control group and 19% in the treatment group (P < 10(-6)). The total 2-year rate of brain metastasis was 67% and 40%, respectively (relative risk = 0.35; P < 10(-13)). The 2-year overall survival rate was 21.5% in the control group and 29% in the treatment group (relative risk = 0.83; P = .14). There were no significant differences between the two groups in terms of neuropsychological function or abnormalities indicated by computed tomography brain scans. CONCLUSIONS: Prophylactic cranial irradiation given to patients with small-cell lung cancer in complete remission decreases the risk of brain metastasis threefold without a significant increase in complications. A possible beneficial effect on overall survival should be tested with a higher statistical power. IMPLICATIONS: The results of the trial favor, at present, the indication of prophylactic cranial irradiation for patients who are in complete remission. A longer follow-up and confirmatory trials are needed to fully assess late-occurring toxic effects. The possible effect on overall survival needs to be evaluated with a larger number of patients in complete remission, and a meta-analysis of similar trials is recommended.

Aged↗