Effect Of Adjuvant Radiotherapy Research Articles

Impact of Adjuvant Radiotherapy and Reversibility of Neurogenic Bladder on Bladder Storage Function and Impact of Urethral Resistance on Bladder Emptying Function after Radical Hysterectomy

Purpose: To clarify which patients need careful neurourological management after abdominal radical hysterectomy (RH) by investigating the effects of adjuvant radiotherapy and reversibility of neurogenic bladder (NB) on the storage function as well as the effects of urethral resistance on the emptying function. Methods: Data from sixty-two patients referred to our NB clinic after RH were retrospectively reviewed. Findings of urodynamic studies performed at 3 (UDS-1) and 12 (UDS-2) months after treatment were compared, and logistic analysis was used to calculate the odds ratio (OR) of the effects of radiotherapy and irreversible NB on decreased bladder capacity and decreased compliance. Irreversible NB was defined as the need for clean intermittent catheterization at the last follow-up. Results: At the median follow-up period of 41 months, 60% of the patients continued to require clean intermittent catheterization. Of patients with irreversible NB and radiotherapy, 80% had decreased bladder capacity and decreased compliance at UDS-2. For decreased bladder capacity and decreased compliance, ORs of adjuvant radiotherapy at UDS-2 were 38.42 (p < 0.001) and 7.46 (p = 0.001), respectively, while ORs of irreversible NB were 1.64 (p = 0.527) and 3.42 (p = 0.062), respectively. Detrusor contraction could be demonstrated in only 15% and 45% at UDS-1 and UDS-2, respectively. However, regardless of improvement in detrusor contractility, urodynamic studies revealed a high urethral resistance. Conclusions: Careful neurourological follow-up after RH is mandatory for patients who undergo adjuvant radiotherapy and have irreversible NB with impaired urethral relaxation.

Disscussion and analysis of the effect of adjuvant radiotherapy after neoadjuvant chemotherapy for stage T1-2N1M0 breast cancer

Objective To evaluate the effects and significance of adjuvant radiotherapy after neoadjuvant chemotherapy on local recurrence (LR) rate in patients with stage T1-2N1M0 breast cancer. Methods Clinical data were collected from patients with stage T1-2N1M0 breast cancer who were admitted to our hospital and treated with neoadjuvant chemotherapy from 2005 to 2010. The clinical outcomes in those patients were analyzed after treatment with adjuvant radiotherapy. A total of 144 patients with a median age of 45 years (23-72 years) were enrolled as subjects. Results In the 144 patients, 30 patients (21%) who had pathological complete response (pCR) in primary breast tumor and axillary lymph node received adjuvant radiotherapy; 10 out of 45 patients who had pCR in axillary lymph node alone did not receive adjuvant radiotherapy; 6 out of 69 patients who still had axillary lymph node metastasis after treatment did not receive adjuvant radiotherapy; all of the rest received adjuvant radiotherapy. In all patients, the median follow-up time was 88 months; 46 patients (32%) had relapse and metastasis. The 5-year LR rate was 3.0% in patients with pCR. In patients with pCR in axillary lymph node metastasis after neoadjuvant chemotherapy, there was no significant difference in the 5-year LR rate between patients treated with and without radiotherapy (7% vs. 16%, P=0.181). In patients with axillary lymph node metastasis after neoadjuvant chemotherapy, there was also no significant difference in the 5-year LR rate between patients treated with and without radiotherapy (15.9% vs. 33.3%, P=0.267). In all patients, those with pCR had significantly longer disease-free survival (DFS) time than those without pCR (P=0.017). Conclusions Patients with pCR to neoadjuvant chemotherapy have longer DFS time than those without pCR. The LR rate is relatively lower in patients with pCR undergoing adjuvant radiotherapy. Patients with pCR in axillary lymph node metastasis do not benefit from postoperative adjuvant radiotherapy. However, adjuvant radiotherapy is helpful in patients with axillary lymph metastasis after neoadjuvant chemotherapy who have high LR rates Key words: Breast neoplasms/neoadjuvant chemotherapy; Pathological complete response; Breast neoplasms/adjuvant radiotherapy

Effects of adjuvant radiotherapy on completely resected gastric cancer: A radiation oncologist’s view of the ARTIST randomized phase III trial

PurposeWe investigated which subgroups might benefit from adjuvant radiotherapy (RT) and suggested optimal RT targets by analyzing the results of the Adjuvant Chemoradiation Therapy in Stomach Cancer (ARTIST) trial. MethodsWe conducted randomized controlled trial in 458 gastric cancer patients. Patients were randomly assigned to XP (6 cycles of capecitabine and) or XPRT (2 cycles of XP+RT 45Gy/25 fraction with capecitabine+2 cycles of XP) groups after D2 resection. Minimum follow-up was 5years. ResultsDuring follow-up, 77 patients (33.8%) in the XP arm and 60 (26.1%) in the XPRT arm experienced recurrence. Among these patients, locoregional recurrence (LRR) developed in 44 (9.6%; 29 in XP, 15 in XPRT; P=0.03). The local recurrence rate (4.8%) did not vary between arms. Regional recurrence was the most important difference between the two groups (23 in the XP arm, 5 in the XPRT arm, P<0.001). LRR-free survival (LRRFS) was significantly different between study arms (P=0.03), especially in patients with LN metastasis (P=0.009). ConclusionsAdjuvant RT after D2 resection in gastric cancer reduced LRR, especially in group 3 LNs, and improved LRRFS. Patients with LN metastasis benefited more from the adjuvant RT treatment than the other subgroups.

The effect of adjuvant radiotherapy on survival in locoregional urothelial malignancies of the upper urinary tract.

e15636 Background: While radical nephroureterectomy is the treatment of choice for localized or regional urothelial carcinoma of the upper urinary tract, the role of adjuvant radiotherapy is unknow...

ADJUVANT RADIOTHERAPY FOR LOW AND MODERATE RISK ENDOMETRIAL CANCER: PRO AND CONTRA

Most patients with endometrial cancer (EC) have stage I disease, the treatment of choice is a total hysterectomy with bilateral salpingo-oophorectomy with or without pelvic lymphadenectomy. Concerning adjuvant radiotherapy for early endometrial cancer is unclear and determined by the risk of recurrence. In accordance with the depth of invasion of the myometrium, histological type and degree of differentiation stage I endometrial cancer is classified into low, intermediate and high risk of lymph node and distant metastasizing. Randomized studies have shown significant improvement in local control after radiation of pelvis and/or intracavitary radiation of the vagina without improving overall survival among patients of high and intermediate risk. At the same time the most controversy associated with the using of adjuvant radiation therapy in intermediate risk EC due to the heterogeneity of the group, which required selection of a subgroup of high intermediate risk, taking into account additional factors: lymphovascular invasion and age. In a subgroup of high-intermediate risk loco-regional effect of adjuvant radiotherapy was more significant. Taking into account the heterogeneity of patients with early EC, the complexity of the assessment of prognosis in case of not provided regional lymphadenectomy and the risk of late radiation complications attempts to optimize the indications, the volume and method of adjuvant radiation therapy in accordance with the risk factors.

Effectiveness of adjuvant radiotherapy after local excision of rectal cancer with deep submucosal invasion: a single-hospital, case-control analysis.

The role of postoperative radiation therapy (RT) after local excision (LE) of deep submucosal invasive rectal cancer remains unclear. We evaluated the efficacy of adjuvant RT after LE of early rectal cancer with deep submucosal invasion. We screened 227 patients who underwent transanal excision or endoscopic removal of deep submucosal invasive rectal cancer between 1992 and 2012, of which 66 did not undergo radical surgery owing to the patient's preference or poor medical conditions. Of these, 35 (53%) underwent LE alone (LE group) and 31 (47%) received adjuvant RT after LE (LE+RT group). Nine patients in the RT group received concurrent adjuvant chemotherapy with 5-fluorouracil. Two independent pathologists reviewed histological data. The mean age of patients in the LE+RT and LE groups was 59.5±9.6 and 55.3±11.2years, respectively. The mean follow-up duration was 78.7±66.7months in the LE+RT group and 70.5±45.7months in the LE group. Cancer eventually recurred in six patients (9.1%; two in the LE+RT group and four in the LE group). In five of these patients, recurrence occurred within 4years after the initial treatment. The other patient, who was in the LE group, exhibited multiple lymph node metastases at the 116-month follow-up. Kaplan-Meier estimates of recurrence-free survival at 5years after treatment were 96.8% in the LE+RT group and 97% in the LE group (P=0.657). RT after LE of early rectal cancer with deep submucosal invasion might not improve recurrence-free survival compared with LE alone.

Analysis of the effect of adjuvant radiotherapy on outcome and complications after radical hysterectomy in FIGO stage IB1 cervical cancer patients with intermediate risk factors

Background There are no definitive criteria for identifying which patients with The International Federation of Gynecology and Obstetrics (FIGO) stage IB cervical cancer will benefit from adjuvant therapy after radical hysterectomy. The aims of this study were to clarify the efficacy of adjuvant therapy and assess complications after radical hysterectomy in patients with FIGO stage IB1 cervical cancer with intermediate risk factors.

Transplant of an Autologous Platelet Gel Prosthesis to Fill Defects After Tumor Excision

Tumor excision causes disfigurement in the breast. We present our technique for filling the defect with activated platelet gel, thus avoiding the deformity. Between 2006 and 2011, 23 patients (age range, 45-72 years) underwent tumorectomy for breast cancer. After estimating and extracting the volume of blood required, we centrifuged the blood at 1800 rpm for 8 minutes. Later, the middle and lower thirds of the plasma) were separated and activated with CaCl₂ at a ratio of 1/20, forming a gel, which was used to fill the tumorectomy cavity. Imaging tests (ultrasound, mammography, and magnetic resonance imaging) performed 12 months after surgery revealed scar tissue in the area where the autoprosthesis had been inserted. Magnetic resonance imaging showed no retraction or deformity in the skin silhouette. Histology study after 1 year demonstrated that the platelet gel had been replaced by fibrous scar tissue with dense collagen and the presence of small capillary vessels. Patients recorded high rates of satisfaction. This technique maintains the shape and volume of the breast, avoiding deformities and retractions of the nipple areola complex by filling the defect with an autoprosthesis. After 12 months, the autoprosthesis had been replaced by fibrous tissue and dense collagen. Postoperative control was good, and the effectiveness of adjuvant radiotherapy or chemotherapy was not altered. No cases of tumor relapse were recorded. On palpation, consistency and softness were similar to that of breast tissue. The aesthetic results were highly satisfactory.

Effect of Adjuvant Radiotherapy in the Management of Hemangiopericytoma of the Central Nervous System:Report of 5 Cases

Objective: Primary intracranial or spinal hemangiopericytoma (HPC) represents a rare tumour that is more difficult to distinguish from other CNS tumours based on clinical symptoms and imaging findings. In this article, here we present 5 cases with HPC (3 intracranial and 2 spinal) with histologically confirmed were treated at our hospital between June 2009 to January 2010, and a review of the literature pertaining to the diagnosis, clinical management, and so on. Methods: Clinical data of the 5 patients with HPCs from cerebra and spinal cord including the manifestations of imaging, pathology, treatment and prognosis factors were investigated, and relevant literatures were reviewed. Of which, 3 males, 2 females, age ranged from 6-35 years old, median age at primary diagnosis was 29 years. Results: 3 patients underwent craniotomy and the other 2 patients underwent spinal surgery. Total mass removal was achieved in 1 case and subtotal removal in 4 cases. All 5 patients received radiotherapy after resection, A total dose of 59.4 Gy/33f was delivered in a fractionation of 5 x1.8 Gy per week for the 3 patients with cerebral lesions using three dimensional conformal radiation therapy (3D-CRT) or intensive modulated radiation therapy (IMRT) technique, and 45Gy in 25 fractions for the 2 patients with spinal lesions. The patients were followed up varied from 6 to 27 months, and none of the patients was found with evidence of radiation complications. Acute toxicity was mild including skin erythema and alopecia. Follow-up of the patients has not yet discovered that a tumour recurrence and extra-cranial metastasis all remain alive up to date. Conclusions: Multidisciplinary care should be highly advocated in the management of intracranial or spinal HPC. Surgical resection, either complete or subtotal excision, followed by postoperative radiotherapy, will provide the patients with higher probability for disease-free survival.

Abstract P4-13-14: Lung cancer after treatment of breast cancer:retrospective study from Curie Institut

Abstract Background: Few studies have evaluated the effects of adjuvant radiotherapy (RT)of breast cancer(BC). The relation between the risk of lung carcinoma and radiotherapy have been controversial. Methods and materials: We retrospectively studied 127 patients treated at the Institut Curie with non metastatic breast cancer and lung carcinoma between 2000 and 2011(2/3 of BC apperead befor lung). Confirmation Diagnosis bronchial cancer obtained by: biopsy: histological data:architecture, IHC (HR, HER 2, TTF1), EGFR, Kras statut clinical and radiological Correlation. Comparison with breast tumor Results: BC: median age at diagnosis 54 years, predominatly invasive ductual carcinoma(IDC), lumpectomy 78%, mastectomy 21%. Lung cancer: median age at diagnosis: 63 years, 67 smokers. histology: 52 % Adenocarcinoma, 18.1 % scamous cell carcinoma, 18.1% large cell carcinoma, 13.4 % small cell carcinoma. EGFR mutation in 4.3%. 109 patients underwent RT (3 cases of lung cancer befor BC):Region: internal mammary chain: 46, supracalvicular: 42, axillary: 21. Technique: lateral decubitus position: 44, dorsal decubitus position: 57. Interval between breast and lung cancer: 0–3 years: 24.4%, 3–5 years: 15%, 6–10years: 16.5%, 11–20 years: 28%, &amp;gt;20 years: peak of incidence of lung cancer in the 3 years of diagnosis of breast cancer: 24.4 %. There was no apparent relation between treatment of BC and relative risk of developing lung carcinoma. 2nd peak between 11–20 years: 32 % patients, suggest that RT may increase risk of lung carcinoma (latency period for radiation induced second malignancy). Conclusion: This study suggest that adjuvant RT is associated with a real but small risk of developing lung carcinoma. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P4-13-14.

Adjuvant radiotherapy after primary surgical resection in patients with adrenocortical carcinoma: Retrospective cohort analysis.

4641 Background: Adrenocortical carcinoma (ACC) is a rare malignancy with high recurrence and mortality rates. The role of adjuvant radiotherapy (RT) to improve outcome remains unclear. Considering the rarity of ACC, we conducted a historical cohort study to ascertain the effect of adjuvant RT on overall survival and recurrence rates. Methods: Patients were selected from the MD Anderson Cancer Center (MDACC) ACC registry (1998- 2011) who had primary tumor resection with no evidence of distant metastasis at the time of initial diagnosis and a minimum follow-up of 6-months. The adjuvant RT group included patients who received adjuvant RT within 3 months of diagnosis. Control group included patients who did not receive RT and matched based on resection margin status and stage at diagnosis. Results: There were no significant differences between the adjuvant RT group (n=15) and comparison group (n =45) in gender distribution, age, tumor size, functional status, and use of adjuvant mitotane therapy. On multivariate Cox proportional hazard model for overall survival, the adjuvant RT group had hazard ratio of 1.981(95% confidence interval [CI] 0.894-4.391, p=0.0922) compared to the control group. The differences in median time to local recurrence, distant recurrence and of recurrence free survival were not significant between the two groups. In subgroup analysis including only the patients whose initial treatments were from outside of MDACC, RT group (n=15) had hazard ratio of overall survival of 1.604 (95% CI 0.712- 3.613, p=0.2543) compared to group without adjuvant RT (n= 32). Median times to local recurrence, distant recurrence, or of recurrence free survival were also not significantly different between the two groups. Conclusions: To our knowledge, this is the largest single institution report about adjuvant RT use in ACC. In our study, RT did not appear to cause a significant difference in overall survival, recurrence rate, or time to recurrence. However, it is still possible that patients offered adjuvant RT and control groups may have been inherently different. Hence, a prospective study is needed to clarify the role of adjuvant RT in patients with resectable ACC.

A Meta-analysis on Effects of Adjuvant Radiotherapy after Radical Resection of Thymoma

Objective Our goal was to evaluate whether patients with completely resected thymoma were able to benefit from postoperative radiotherapy.Methods Three databases(including EMBASE,CINAHL,and MEDLINE) were searched as well as reference lists of articles and contacted authors were screened.Randomized controlled trails and controlled clinical trials were identified.Data were estimated with the Cochrane collaboration's RevMan 4.3 software.Results Seven controlled clinical trials involving 740 patients were included.Meta-analysis showed that there were no significant differences in recurrence rates and survival rates between radiantion group and no radiantion group,OR=1.36,95% CI(0.42,4.46),P=0.61,and OR=1.45,95% CI(0.86,2.44),P=0.16,respectively.Conclusion The adjuvant radiotherapy after complete resection of thymoma was albe to reduce the recurrence rates or improve the survival rates,and should not used routinely for patients after complete resection.

Histotype predicts the curative potential of radiotherapy: the example of ovarian cancers

BackgroundTo explore the influence of ovarian cancer histotype on the effectiveness of adjuvant radiotherapy (RT). MethodsA review of a population-based experience included all referred women with no reported macroscopic residuum following primary surgery who underwent adjuvant platin-based chemotherapy (CT), with or without sequential RT, and for whom it was possible to assign histotype according to the contemporary criteria. ResultsSeven hundred and three subjects were eligible, of these 351 received RT. For those with apparent stage I and II tumors, the cohort with clear cell (C), endometrioid (E), and mucinous (M) disease who additionally received RT exhibited a 40% reduction in disease-specific mortality and a 43% reduction in overall mortality. ConclusionsThe curability of those with stage I and II C-, E-, and M-type ovarian carcinomas was enhanced by RT-containing adjuvant therapy. This benefit did not extend to those with stage III or serous tumors. These findings necessitate reassessments of the role of RT and of the nonselective surgical and CT approaches that have characterized ovarian cancer care.

Can Bcl-XL expression predict the radio sensitivity of Bilharzial-related squamous bladder carcinoma? a prospective comparative study

BackgroundLocal pelvic recurrence after radical cystectomy for muscle invasive bilharzial related squamous cell carcinoma accounts for 75% of treatment failures even in organ confined tumors. Despite the proven value of lymphadenectomy, up to 60% of patients undergoing cystectomy do not have it. These factors are in favor of adjuvant radiotherapy reevaluation. objectives: to evaluate the effect of adjuvant radiotherapy on disease free survival in muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder and to test the predictability of radio-sensitivity using the anti apoptotic protein Bcl-XL.MethodsThe study prospectively included 71 patients, (47 males, 24 females) with muscle invasive bilharzial related squamous cell carcinoma of the bladder (Stage pT2a-T3N0-N3M0) who underwent radical cystectomy in Assiut university hospitals between January 2005 and December 2006. Thirty eight patients received adjuvant radiotherapy to the pelvis in the dose of 50Gy/25 fractions/5 weeks (Group 1), while 33 patients did not receive adjuvant radiotherapy (group 2). Immunohistochemical characterization for bcl-xL expression was done. Follow up was done every 3 months for 12 to 36 months with a mean of 16 ± 10 months. All data were analyzed using SPSS version 16. Three years cumulative disease free survival was calculated and adjusted to Bcl-XL expression and side effects of the treatment were recorded.ResultsThe disease free cumulative survival was 48% for group 1 and 29% for group 2 (log rank p value 0.03). The multivariate predictors of tumor recurrence were the positive Bcl-XL expression (odd ratio 41.1, 95% CI 8.4 - 102.3, p < 0.0001) and radiotherapy (odd ratio 0.19, 95% CI 0.05 - 0.78, p < 0.02). With Cox regression, the only independent multivariate predictor of radio-sensitivity was the Bcl-XL expression with odd ratio 4.6 and a p value < 0.0001. All patients tolerated the treatment with no life threatening or late complications during the period of follow up.ConclusionsAdjuvant radiotherapy for muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder has potential effectiveness and minor side effects. Moreover, Bcl-XL expression is a valuable tool for predicting those who might not respond to this adjuvant treatment.

Survival Outcomes in Resected Extrahepatic Cholangiocarcinoma: Effect of Adjuvant Radiotherapy in a Surveillance, Epidemiology, and End Results Analysis

The benefit of adjuvant radiotherapy (RT) after surgical resection for extrahepatic cholangiocarcinoma has not been clearly established. We analyzed survival outcomes of patients with resected extrahepatic cholangiocarcinoma and examined the effect of adjuvant RT. Data were obtained from the Surveillance, Epidemiology, and End Results (SEER) program between 1973 and 2003. The primary endpoint was the overall survival time. Cox regression analysis was used to perform univariate and multivariate analyses of the following clinical variables: age, year of diagnosis, histologic grade, localized (Stage T1-T2) vs. regional (Stage T3 or greater and/or node positive) stage, gender, race, and the use of adjuvant RT after surgical resection. The records for 2,332 patients were obtained. Patients with previous malignancy, distant disease, incomplete or conflicting records, atypical histologic features, and those treated with preoperative/intraoperative RT were excluded. Of the remaining 1,491 patients eligible for analysis, 473 (32%) had undergone adjuvant RT. After a median follow-up of 27 months (among surviving patients), the median overall survival time for the entire cohort was 20 months. Patients with localized and regional disease had a median survival time of 33 and 18 months, respectively (p<.001). The addition of adjuvant RT was not associated with an improvement in overall or cause-specific survival for patients with local or regional disease. Patients with localized disease had significantly better overall survival than those with regional disease. Adjuvant RT was not associated with an improvement in long-term overall survival in patients with resected extrahepatic bile duct cancer. Key data, including margin status and the use of combined chemotherapy, was not available through the SEER database.

Effect of adjuvant radiotherapy on survival in localized limb or trunk wall well-differentiated liposarcoma (WDLPS).

10079 Background: WDLPS accounts for about 10% of all soft tissue sarcoma and may arise in any part of the body. Whether post operative radiotherapy is useful in the management of these patients after definitive surgery remains unclear. Methods: Searching the online virtual Conticanet tumor bank conticabase, 195 patients with parietal trunk or extremities WDLPS with pathological central review within the French Sarcoma Group pathologist working party were identified. Dedifferentiated, myxoid/round cell and pleomorphic LPS were excluded. Patient had had primary surgery between 1980 and 2008 in 17 French and Swiss medical centers. Prognostic factors for RFS and OS were investigated in univariate and multivariate analysis, including the use of adjuvant external bean radiotherapy (EBR) mostly given in 2gy fractions over 50-60. Results: 96 males and 99 females, with a median age of 60 were identified. Primary sites were lower limb (156, 80%), trunk wall (15, 8%), groin / shoulder girdles (14, 7%), upper limb (10, 5%). Median size of the primary was 17cm (range 3-40). 163 (84%) pts were followed since the first event, 32 (16%) had had prior surgery on the same tumor. 78 (40%), 76 (39%), 4 (2%) had R0, R1, and R2 resection as first treatment respectively, 103 (53%) patients received postoperative radiotherapy (EBR). 163 patients had a primary surgery in a sarcoma center, and 32 had primary surgery in a primary care center. With a median follow-up of 87 months there were 14 deaths, 15 local relapses, no metastatic relapse.Only EBR and proximal/trunk sites were found significantly associated with RFS in univariate analyses, for both the whole series, and the series of patients treated in reference centers. EBR was the only independent parameter for RFS in multivariate analysis. In the group of 163 patients operated upfront in sarcoma centers, gender, age, trunk/proximal sites, R2 resection, EBR, were retained as independent prognostic factors for overall survival in multivariate analysis, along with, primary surgery in a sarcoma center in the whole series. Conclusions: In this series of 195 WDLPS, relapses occurred only locally and post operative radiotherapy was associated with an improved RFS and overall survival. No significant financial relationships to disclose.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

BackgroundModern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation.Methods/DesignThe present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome.ConclusionThe inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study.Trial registrationClinicalTrials.gov: NCT00964977

Survival Analysis of Malignant Peripheral Nerve Sheath Tumor: Effects of Adjuvant Radiotherapy, Extent of Resection, and Tumor Grade

Survival Analysis of Malignant Peripheral Nerve Sheath Tumor: Effects of Adjuvant Radiotherapy, Extent of Resection, and Tumor Grade

C48 The long-term side effects of adjuvant radiotherapy vs carboplatin chemotherapy in clinical stage A seminomatous testicular tumors

C48 The long-term side effects of adjuvant radiotherapy vs carboplatin chemotherapy in clinical stage A seminomatous testicular tumors

The effect of adjuvant radiotherapy on mortality differs according to primary tumor location in women with node-positive breast cancer.

To evaluate the prognostic significance of primary tumor location and to examine whether the effect of adjuvant radiotherapy on survival varies according to tumor location in women with axillary node-positive (ALN+) breast cancer (BC). Data were abstracted from the SEER database for 24,410 women aged 25-95 years, diagnosed between 1988-1997 with nonmetastatic T1-T2, ALN+ BC. Subgroup analyses were performed using interactions within proportional hazards models. Event was defined as death from any cause. Prognostic variables were selected using Akaike Information Criteria. Joint significances of subgroups were evaluated with Wald test. Median follow-up was 10 years. In joint models, statistically significant interactions were found between tumor location, nodal involvement, type of surgery, and radiotherapy. Factorial presentation of interactions showed consistent 13% proportional reduction of mortality in all subgroups, except in women with medial tumors with > or = 4 ALN+ treated with mastectomy. In this subgroup, use of radiotherapy was associated with a 16% proportional increase in mortality. Medial tumor location is a significant adverse prognostic factor that should be considered in treatment decision- making for women with ALN+ BC. Improved survival was observed with radiotherapy use in all subgroups, except in women with medial tumors with > or = 4 ALN+ treated with postmastectomy radiotherapy. These findings raise concern that the favorable effect of radiotherapy may be offset by excess toxicities in the latter subgroup.