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The morbidity of salvage surgery following conventional radiotherapy and continuous, hyperfractionated accelerated radiotherapy (CHART).

A comparison was made of the morbidity of surgery for loco-regional recurrence in patients with advanced cancer of the head and neck region following continuous hyperfractionated accelerated radiotherapy (CHART), after conventional radiotherapy, and also in a group following surgery only as the primary treatment. Post-surgical morbidity occurred in 14 (77%) of the 18 patients treated with CHART, of whom 11 (78%) required a further surgical procedure. In the conventional group, morbidity occurred in 14 (58%) of the 24 patients, of whom 9 (64%) required further surgery. Finally, in the surgical group morbidity occurred in 13 (48%) of the 27 patients, of whom 7 (54%) required further surgery. Because of the many factors that may influence the chance of morbidity and of the small number of cases, considered statistical analysis is not meaningful and there must be caution in the interpretation of results. When allowance is made for the greater frequency of more advanced tumors and for sites in the oropharynx and oral cavity, where procedures associated with greater risk of complication were performed, the morbidity seen after surgery was performed upon CHART patients appeared to be no greater than when conventional radiotherapy had been given. As expected, the surgery only group showed less morbidity than either of the radiotherapy groups.

Adult↗

Xerostomia and quality of life after intensity-modulated radiotherapy vs. conventional radiotherapy for early-stage nasopharyngeal carcinoma: initial report on a randomized controlled clinical trial.

PURPOSE: To compare directly the effect of intensity-modulated radiotherapy (IMRT) vs. conventional radiotherapy (CRT) on salivary flow and quality of life (QoL) in patients with early-stage nasopharyngeal carcinoma (NPC). METHODS AND MATERIALS: Fifty-one patients with T2, N0/N1, M0 NPC took part in a randomized controlled clinical study and received IMRT or CRT. Stimulated whole (SWS) and parotid (SPS) saliva flow were measured and Medical Outcomes Short Form 36 (SF-36), European Organization for Research and Treatment of Cancer (EORTC) core quetionnaire, and EORTC head-and-neck module (QLQ-H&N35) were completed at baseline and 2, 6, and 12 months after radiotherapy. RESULTS: Forty-six patients (88%) were in disease remission 12 months after radiotherapy. At 12 months postradiotherapy, 12 (50.0%) and 20 patients (83.3%) in the IMRT group had recovered at least 25% of preradiotherapy SWS and SPS flow respectively, compared with 1 (4.8%) and 2 patients (9.5%), respectively, in the CRT group. Global health scores showed continuous improvement in QoL after both treatments (p < 0.001). However, after 12 months subscale scores for role-physical, bodily pain, and physical function were significantly higher in the IMRT group, indicating a better condition (p < 0.05). Dry mouth and sticky saliva were problems in both groups 2 months after treatment. In the IMRT group, there was consistent improvement over time with xerostomia-related symptoms significantly less common than in the CRT group at 12 months postradiotherapy. CONCLUSIONS: IMRT was significantly better than CRT in terms of parotid sparing and improved QoL for early-stage disease. The findings support the case for assessment of health-related QoL in relation to head-and-neck cancer using a site-specific approach.

Adult↗

Parotid gland-sparing 3-dimensional conformal radiotherapy results in less severe dry mouth in nasopharyngeal cancer patients: a dosimetric and clinical comparison with conventional radiotherapy.

BACKGROUND AND PURPOSE: This study examined the efficacy of parotid gland sparing of three-dimensional conformal radiotherapy (3DCRT) compared with conventional radiotherapy for NPC patients. Both the dose given to the parotids and clinical assessment of dry mouth were conducted. MATERIALS AND METHODS: Dry mouth was assessed for 108 patients treated with conventional technique and 72 treated with 3DCRT. Dose analysis was performed in 48 patients of the 3DCRT group. A dose of 70 Gy was given to the midplane in conventional radiotherapy and to 90% isodose volume in 3DCRT. Prognostic factors affecting the severity of dry mouth were analyzed using Generalized Estimating Equation (GEE). RESULTS: In the 3DCRT group about 50% of the patients' parotid glands received less than 25 Gy. Parallel analysis of dry mouth shows a significant decrease in the incidence of severe xerostomia after 3DCRT. The proportion of patients without dry mouth was also significantly higher in the 3DCRT group than the conventional group at 1-3 years after completion of radiotherapy. Although 3DCRT delivered a higher dose to the tumor, it spared the parotid gland significantly better than the conventional treatment. Late toxicities were mostly similar between the 2 groups while local control in T4 patients and survival were improved for 3DCRT. CONCLUSION: Dosimetrically and clinically 3DCRT is better than conventional technique regarding parotid gland protection.

Adolescent↗

A long-term visual outcome comparison in patients with optic nerve sheath meningioma managed with observation, surgery, radiotherapy, or surgery and radiotherapy.

PURPOSE: Comparison of treatment outcome in patients with primary optic nerve sheath meningioma (ONSM). DESIGN: Retrospective, nonrandomized, comparative interventional case series. PARTICIPANTS: Sixty-four patients with at least 50 months of well-documented follow-up. INTERVENTION: Observation, surgery only, radiotherapy only, or surgery and radiotherapy. MAIN OUTCOME MEASURES: Visual acuity expressed as ratio, radiographic progression, and treatment complications. RESULTS: Sixty-four patients (55 women [85.9%] and nine men [14.1%]) were followed for a mean of 150.2 months (range, 51-516 months; standard deviation [SD], 74.7). The mean age at diagnosis was 47.1 years (range, 17-81 years; SD, 15.4). Fifty-eight patients had unilateral disease and six patients had bilateral disease. Of 59 patients with vision greater than no light perception at diagnosis, 13 patients were observed only, 12 had surgery only (four biopsies or partial resections, eight total resections), 18 received radiation alone, and 16 had surgery and radiation (14 biopsies or partial resections and radiation, two total resections and radiation). Irradiated patients received 4000 to 5500 cGy of conventional multiport or conformal external beam therapy, typically fractionated over 6 weeks. Visual acuity measurements at diagnosis among the four groups were not different (ratio, P = 0.186). Visual acuity at diagnosis was > or =0.5 in 56.3%, 0.4 to 0.050 in 12.5%, and <0.050 in 31.3%. Visual acuity measures at last follow-up were different among the four groups (ratio, P = 0.004). At last follow-up the acuity was > or =0.5 in 28.1%, 0.4 to 0.050 in 15.6%, and <0.050 in 56.3%. Visual acuity fell significantly for the observed only (ratio, P = 0.002), surgery only (ratio, P = 0.019), and surgery with radiation groups (ratio, P = 0.030). The radiation only group showed a decrease in visual acuity that was not significant (ratio, P = 0.301). Complication rate was 33.3% in radiation only cases, 66.7% in surgery only cases, and 62.5% in surgery with radiation cases. Twenty-one patients (32.8%) showed radiographic progression. Four patients who were observed, seven patients who had surgery alone, and eight patients who had surgery and radiation developed radiographic progression. Two patients who had radiation alone had radiographic progression before treatment. Only two patients treated with radiation only showed radiographic progression after radiotherapy, and both had at least one surgical procedure before the radiotherapy. CONCLUSIONS: Patients with ONSM receiving radiation alone demonstrated the best visual outcome during the follow-up period. We recommend that fractionated external beam radiation (5000-5500 cGy) be considered as initial treatment in adults in selected cases of ONSM when preservation of visual function is a reasonable therapeutic goal.

Adult↗

Knowledge and perception regarding radiotherapy and radiation in patients receiving radiotherapy: a qualitative study.

This study aimed to acquire information about the knowledge patients have about radiation and radiotherapy, and the sources and impact of this knowledge. Data collection was by semi-structured interviews with 30 randomly selected adult patients conducted during the first half of a course of radiotherapy. Data analysis used three major themes: language, understanding and sources of knowledge. Few interviewees had any idea of the physical characteristics of radiation treatment, or they found it difficult to explain. Knowledge about radiation use, other than for medical purposes, most commonly concerned the atom bomb. Patients understood radiotherapy in terms of its action on cancer. Almost all offered a sensible description of why radiotherapy was being used to treat their cancer. Most talked about radiation attacking their cancer in some way and many worried about its damaging effect. A third gave detailed information about what they had become aware of through the written press, or radio or television. The message taken from press reports was largely negative.

Adult↗

Induction chemotherapy plus high-dose radiotherapy versus radiotherapy alone in locally advanced unresectable non-small-cell lung cancer.

BACKGROUND: High-dose radiation therapy is generally recommended as standard treatment in regionally advanced unresectable non-small-cell lung cancer (NSCLC), but median- and long-term survival remain poor. Some reports have recently shown an improvement of results in advanced NSCLC when cisplatin was included in the chemotherapy regimens. Therefore, we designed a randomized trial to determine whether induction chemotherapy before high-dose radiotherapy improves response rate and survival in stage III NSCLC over that achieved with radiotherapy alone. PATIENTS AND METHODS: From March, 1984 to December, 1988, 66 consecutive patients with stage III unresectable NSCLC were randomized to one of two treatment arms; 61 were evaluable for survival and 58 for response and toxicity. Patients randomly assigned to arm A received cisplatin (CDDP 100 mg/m2 on day 1) and etoposide (VP 16 120 mg/m2 on days 1, 2, 3) every 3 wks for 3 courses followed by radiotherapy 56 Gy on pre-treatment tumor volume and 40 Gy on mediastinum and bilateral supraclavicular nodes. Patients assigned to arm B received only the same radiotherapy. The 61 eligible patients were comparable in terms of age, performance status, histology and treatment. RESULTS: Response rate was 53% in arm A and 32% in arm B. The median survival was 52 wks for the combined treatment arm and 36 wks for the radiation therapy arm. At six years of follow-up all the patients were dead. Toxicity was mild and no treatment-related deaths were recorded. CONCLUSION: Induction chemotherapy produced a better response rate and a trend of improved survival (4 months) but a significant survival advantage was not achieved (p < 0.11), probably because of the small number of patients enrolled in the trial.

Aged↗

Induction VBM plus radiotherapy, versus radiotherapy alone for advanced head and neck cancer: long-term results.

Between 1978 and 1981, 85 patients with advanced squamous cell carcinoma of the head and neck were randomized to receive induction VBM followed by radiotherapy, or radiotherapy alone. The shortest follow-up is thus 6 years. The median survival of patients receiving induction chemotherapy was 46 weeks, that of the radiotherapy group alone was 75 weeks. As the two groups were not balanced despite randomization, multivariate methods (GLIM) were used to identify significant prognostic factors. These were: response to radiotherapy (P less than 0.001), nodal status (P less than 0.001), age (P less than 0.01), and histological grade (P less than 0.01). Neither treatment with, nor response to, chemotherapy had a significant effect on survival.

Adult↗

Involved-field radiotherapy is equally effective and less toxic compared with extended-field radiotherapy after four cycles of chemotherapy in patients with early-stage unfavorable Hodgkin's lymphoma: results of the HD8 trial of the German Hodgkin's Lymphoma Study Group.

PURPOSE: To investigate whether radiotherapy can be reduced without loss of efficacy from extended field (EF) to involved field (IF) after four cycles of chemotherapy. PATIENTS AND METHODS: Between 1993 and 1998, patients with newly diagnosed early-stage unfavorable HD were enrolled onto this multicenter study. Patients were randomly assigned to receive cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) + doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for two cycles followed by radiotherapy of 30 Gy EF + 10 Gy to bulky disease (arm A) or 30 Gy IF + 10 Gy to bulky disease (arm B). RESULTS: Of 1,204 patients randomly assigned to treatment, 1,064 patients were informative and eligible for the arm comparison (532 patients in arm A; 532 patients in arm B). The median observation time was 54 months. Five years after random assignment, the overall survival (OSran) for all eligible patients was 91% and freedom from treatment failure (FFTFran) was 83%. Survival rates at 5 years after start of radiotherapy revealed no differences for arms A and B, respectively, in terms of FFTF (85.8% and 84.2%) and OS at 5 years (90.8% and 92.4%). There also were no differences between arms A and B, respectively, in terms of complete remission (98.5% and 97.2%), progressive disease (0.8% and 1.9%), relapse (6.4% and 7.7%), death (8.1% and 6.4%), and secondary neoplasia (4.5% and 2.8%). In contrast, acute side effects including leukopenia, thrombocytopenia, nausea, gastrointestinal toxicity, and pharyngeal toxicity were more frequent in the EF arm. CONCLUSION: Radiotherapy volume size reduction from EF to IF after COPP + ABVD chemotherapy for two cycles produces similar results and less toxicity in patients with early-stage unfavorable HD.

Adolescent↗

[Postoperative radiotherapy in lung cancer: comments on several randomized trials or the contribution of well-conducted radiotherapy].

Postoperative radiotherapy is classically proposed after surgical resection in case of a high risk of local recurrence (incomplete resection and nodal invasion especially mediastinal). Its interest was shown by non-randomized trials. Nevertheless, several randomized trials and one meta-analysis of them have recently questioned the contribution of radiotherapy. We analyze here these trials then the meta-analysis, emphasizing certain methodology problems such as the noninclusion of certain therapeutic trials and differences in radiotherapy dosages and techniques. In our opinion, excessive toxicity observed in certain trials can be attributed to technical errors; if well conducted, postoperative radiotherapy improves survival in operated patients when there is a high risk of local reccurence. This affirmation is based on a comparison of long term results of 347 non randomized cases with Port Meta-Analysis randomized cases and GETCB trial randomized cases.

Clinical Trials as Topic↗

Therapeutic effect of high-dose three-dimensional conformal radiotherapy and conventional radiotherapy for non-small-cell lung cancer.

OBJECTIVE: To improve the therapeutic effect of radiotherapy without increasing the risk of radiation injury in patients with non-small cell lung cancer (NSCLC). METHODS: From August 1998 to August 1999, 135 patients with NSCLC received radiotherapy, of whom 62 were treated with high-dose three-dimensional conformal radiotherapy (3D-CRT) at the total dose of 48 to 64 Gy in 6 to 8 fractions implemented in a course of 2 to 3 weeks, 6 to 8 Gy for each fraction. The other 73 patients underwent conventional radiotherapy (CR) at the total dose of 60 to 70 Gy in 30 to 35 fractions completed in 6 to 7 weeks. Follow-up study was conducted in all the cases, and CT-scan or magnetic resonance imaging was performed once every 3 months after the therapy to assess the local control rate, survival rate, radiation-induced lung and esophageal injuries. RESULTS: Three months after radiation therapy, complete remission of the lesions was achieved in 44.9% (CR group) and 77.8% (3D-CRT group) of the cases with the efficacy rates of 94.4% and 100% respectively, showing significant differences between the 2 groups (P<0.01). The 1- and 2-year survival rate of the patients in the 2 groups were 42.5% vs 77.8% and 30.1% vs 48.6% respectively, also with significant differences between the 2 groups (P<0.01). Significant difference also occurred in the 1- and 2-year local control rates between the 2 groups, but not in the incidences of radiation-induced lung and esophageal injuries. CONCLUSION: 3D-CRT may yield better therapeutic effect than CR does and has comparable safety with the latter.

Adult↗

[Respiratory gated radiotherapy: the 4D radiotherapy].

Respiration-gated radiotherapy offers a significant potential for improvement in the irradiation of tumor sites affected by respiratory motion such as lung, breast and liver tumors. An increased conformality of irradiation fields leading to decreased complications rates of organs at risk (lung, heart...) is expected. Respiratory gating is in line with the need for improved precision required by radiotherapy techniques such as 3D conformal radiotherapy or intensity modulated radiotherapy. Reduction of respiratory motion can be achieved by using either breath hold techniques or respiration synchronized gating techniques. Breath hold techniques can be achieved with active, in which airflow of the patient is temporarily blocked by a valve, or passive techniques, in which the patient voluntarily breath-hold. Synchronized gating techniques use external devices (CCD camera for the GEMS/Varian system tested at Curie Institute) to predict the phase of the respiration cycle while the patient breaths freely. A new strategy is currently developed: the 4D Respiration correlated CT. It consists of retrospectively reconstruct CT slices at different phases of the breathing cycle allowing to measure residual movements and to choose the optimal patient's breathing phase where tumor movements are lower. These techniques presently investigated in several medical centers worldwide. The first results are very promising.

Breast Neoplasms↗

[Radiation therapy of esophageal cancer--radical radiotherapy and radiotherapy in combination with surgery].

The role of radical and palliative radiotherapy, and radiotherapy combined with surgery are discussed. Surgical resection and radiation therapy have been applied to curative treatment of carcinoma of esophagus. Despite of recent advances of surgery, the results are still unfavorable. Radical irradiation was applied to attempt at long term control of the local and regional disease despite dismal cure rate: doses in the range of 6000 to 7000 rad were required. Palliative irradiation is also achieved significant improvement, and dose range of 4000 to 5000 rad were required. The lesions of cervical or upper one third of the esophagus showed better prognosis by radiotherapy than the lower lesions. Prognosis was related to the size of the lesion and the depth of penetration of the esophageal wall. To improve the treated result, pre- or post operative radiotherapy was tried in combination with surgery. Preoperative irradiation has improved the surgical resectability and treatment result, which was contributed by the recent advances of surgical technique which made extended operation possible. Therefore, the role of preoperative irradiation should be re-evaluated. Postoperative prophylactic irradiation was used to control the possible improvements of mediastimun and/or neck nodes. The treatment results were better in the group of postoperative irradiation than in the group without irradiation.

Adult↗

[Virtual bolus for inversion radiotherapy planning in intensity-modulated radiotherapy of breast carcinoma within the scope of adjuvant therapy].

BACKGROUND: Intensity modulated radiotherapy (IMRT) provides better sparing of normal tissue. We investigated the feasibility of inverse treatment planning for IMRT in adjuvant radiotherapy for breast cancer. MATERIAL AND METHODS: In addition to radiotherapy planning in conventional technique with tangential wedged 6-MV-photon beams we performed inversely planned IMRT (KonRad). In the CT scans for treatment planning we defined a 10-mm bolus of -60 HE density. The influence of this bolus on planning optimization was determined by optimization without and dose calculation with and without bolus. Dose calculation after dose optimization with bolus was performed using different bolus thickness to determine the influence of the bolus on dose calculation. The results were compared with dose distribution in conventional technique. RESULTS: Inverse optimization with a dose algorithm which considers tissue inhomogeneity results in unintended dose increase at the patient surface. With a virtual 10-mm bolus used for inverse optimization the dose increase was reduced. Thus, skin sparing was identical to conventional planning. The relative dose distribution was negligibly affected by the use of a 10-mm bolus. Difference in absolute dose was 3.4% compared to calculation without bolus. Therefore, the bolus must be removed before final dose calculation. CONCLUSION: The realization of inverse optimization for IMRT of the breast requires the use of a virtual bolus. Thereby, IMRT in accordance to the consensus recommendations of the EORTC, BCCG and EUSOMA is possible. Especially, the same target definition as in conventional technique may be used. IMRT techniques with a conventional beam arrangement of two tangential fields or multiple beam techniques can be realized.

Algorithms↗

Three-dimensional conformal radiotherapy in the treatment of prostate cancer in Australia and New Zealand: Report on a survey of radiotherapy centres and the proceedings of a consensus workshop.

There is an increasing use of 3-D conformal radiotherapy (3DCRT) in the radiotherapeutic management of prostate cancer. The Faculty of Radiation Oncology Genito-Urinary Group carried out a survey of Australian and New Zealand radiotherapy centres in the preparation of a consensus workshop. Of the 19 centres that were represented, there were 24 radiation oncologists, 16 radiation therapists and 12 medical physicists. The survey collected demographic information and data on the practices undertaken at those centres when delivering curative radiotherapy in the treatment of prostate cancer. There was much variation in the delivery of treatment in the areas of patient set-up, contouring of target volumes and organs of interest during computer planning, the techniques and the dose constraints used in these techniques, the use of adjuvant androgen deprivation therapy and the quality assurance processes used in monitoring effects of treatment. This variability reflects the range of data in the published literature. Emerging trends of practices were also identified. This is a first report on a multi-disciplinary approach to the development of guidelines in 3DCRT of prostate cancer.

Australia↗

Combined chemotherapy and radiotherapy (without surgery) compared with radiotherapy alone in localized carcinoma of the esophagus.

BACKGROUND: Esophageal carcinoma can be managed primarily with either a surgical or non-surgical radiotherapeutic approach. Combination chemotherapy (CT) and radiotherapy (RT) has been incorporated into clinical practice and applied increasingly, especially in North America. OBJECTIVES: To evaluate combined CT and RT (CTRT) versus RT alone in patients with localized esophageal carcinoma. Outcomes included overall survival, cause-specific survival, local recurrence, dysphagia relief, quality of life, acute and chronic toxicities. SEARCH STRATEGY: The Cochrane strategy for identifying randomized trials was combined with relevant MeSH headings. The Cochrane Library, MEDLINE, CancerLIT and EMBASE were last searched in April 2005. References from relevant articles and personal files were included. SELECTION CRITERIA: Randomized controlled trials in patients with localized esophageal cancer comparing RT alone with combined CTRT were included. Studies comparing non-chemotherapy agents such as pure radiotherapy sensitisers, immunostimulants, planned esophagectomy, were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data independently. Trial quality was assessed using the Jadad scale and Detsky checklist. Sensitivity analyses were planned to examine the effect of concomitant versus sequential treatment, study quality, radiotherapy dose, and whether the drug regimen contained cisplatin or 5-fluorouracil were performed. MAIN RESULTS: Nineteen randomized trials were included, with eleven concomitant and eight sequential RTCT studies. Concomitant RTCT provided significant reduction in mortality with a harms ratio (HR) of 0.73 (95% confidence interval (CI) 0.64 to 0.84). Using an estimated mortality rate for the control group of 62% at year one and 83% at year two, the absolute survival benefit for RTCT was 9% (95% CI 5 to 12%) and 4% (95% CI 3 to 6%]) respectively. There was an absolute reduction of local recurrence rate of 12% (95% CI 3 to 22%), number needed to treat (NNT) of 9, when the local recurrence rate for the RT alone arm was 68%. This was associated with a significant risk of severe and life-threatening toxicities (number needed to harm (NNH)of 6). Sensitivity analyses did not identify any factors that interacted with the results. The results from sequential RTCT studies showed no significant benefit in survival or local control but significant toxicities. AUTHORS' CONCLUSIONS: Based on the available data, when a non-operative approach is selected then concomitant RTCT is superior to RT alone for patients with localized esophageal cancer but with significant toxicities. In patients who are in good general condition, and the risk benefit has been thoroughly discussed with the patient, concomitant RTCT should be considered for the management of esophageal cancer compared with radiotherapy alone.

Combined Modality Therapy↗

An intra-patient dose-escalation study of disodium pamidronate plus radiotherapy versus radiotherapy alone for the treatment of osteolytic metastases. Monitoring of recalcification using image-processing techniques.

OBJECTIVE: To evaluate the clinical benefit and mainly to monitor quantitatively the recalcification of osteolytic lesions after radiotherapy with or without intravenous infusion of disodium pamidronate (DP) in different doses. PATIENTS AND METHODS: 42 patients with solitary lytic metastasis in weight-bearing bones were studied. Primary endpoints were the mean value and energy of gray-level histogram in plain radiographs (MVGLH and EGLH) and relative electron density (RED) of CT scans in bone lesions. In eleven patients (group A) the DP dose was increased stepwise from 90 up to 180 mg (flat dose), while in other 15 patients (group B) a flat dose of 180 mg was administered intravenously in 2 h. In both groups, the first session of DP was given concurrently with local radiotherapy (30 Gy in ten fractions, 5 days a week). Another 16 patients (group C) underwent radiotherapy only. RESULTS: Morbidity related to pamidronate was mild. Significant differences from the baseline (p < 0.05, Wilcoxon test) were recorded for MVGLH, EGLH and RED values, regarding all groups. Improvement was significantly higher in patients of group B versus A, while the results of pamidronate groups (A and B) were superior to group C, concerning the above indices (p < 0.05, Mann-Whitney test). Additionally, pamidronate groups had significantly lower skeletal morbidity than group C. CONCLUSION: The 2-h infusional flat dose of 180 mg every 4 weeks seems to be tolerable and superior to 90 mg regarding palliation and mainly recalcification of osteolytic lesions. Radiotherapy alone is effective but inferior to the combined treatment. Last but not least, the findings of MVGLH, EGLH and RED indicate an important increase in bone mass and bone formation, which was difficult to be identified visually by the experts.

Adult↗

Phase III study on the treatment of women with cervical cancer, stage IIB, IIIB, and IVA (confined to the pelvis and/or periaortic nodes), with radiotherapy alone versus radiotherapy plus immunotherapy with intravenous Corynebacterium parvum: a Gynecologic Oncology Group Study.

A report on a study conducted under the auspices of the Gynecologic Oncology Group on the treatment of women with advanced carcinoma of the uterine cervix (stages IIB, IIIB, IVA) with radiotherapy alone versus radiotherapy plus immunotherapy (intravenous Corynebacterium parvum) is presented. There were 283 patients considered evaluable for analysis. Of these, 135 patients were randomized to radiotherapy plus C. parvum (120 patients received at least one course) and 148 were randomized to radiotherapy only. The two treatment regimens were similar for those adverse effects commonly associated with radiation therapy but for hematologic toxicity and fever and/or chills were significantly more frequent among those patients who received C. parvum. There was no statistical difference in the treatment regimens with regard to survival or progression-free interval. Of the 42 patients with positive periaortic nodes, 19% were alive at 3 years. No therapeutic value was demonstrated by combining C. parvum therapy with traditional radiation therapy in advanced cervical cancer. Because of the greater frequency of adverse effects in those patients receiving C. parvum, the further use of C. parvum at this dose and schedule does not appear to be indicated for treating cervical cancer patients.

Adenocarcinoma↗

Radiotherapy alone versus combined chemotherapy and radiotherapy in unresectable non-small cell lung carcinoma.

We report the results observed in a large randomized study comparing radiotherapy alone to combined radiotherapy and chemotherapy in unresectable squamous cell and large cell lung carcinoma. Radiation dose was 65 Gy in both groups and chemotherapy included vindesine, cyclophosphamide, cisplatin and lomustine. One hundred seventy-seven patients received radiotherapy alone, and 176 received the combined treatment. The 2-year survival rate was 14% for patients receiving radiotherapy vs. 21% for patients receiving the combined treatment (P = 0.02). The distant metastasis rate was significantly lower in the group receiving the combined treatment (P < 0.001). Local control at 1 year was poor in both groups (17% and 15%, respectively) and remains a major problem in locally advanced non-small cell lung cancer.

Antineoplastic Combined Chemotherapy Protocols↗