Pelvic External Beam Radiotherapy Research Articles

Radiation therapy with concurrent chemotherapy for locally advanced cervical carcinoma: outcome analysis with emphasis on the impact of treatment duration on outcome.

Objective. To assess the effectiveness and toxicity of carboplatin concurrent with pelvic external beam radiation and low-dose rate brachytherapy and to assess the impact that adherence to the treatment plan has on outcomes. Methods. Retrospective chart review of 56 patients treated from January 2001 to December 2010. Results. Median follow-up was 68 months. Optimal dose of radiation (ORT) was defined as a minimal cervical dose exceeding 70 Gy, point A dose of 80–90 Gy, and duration not exceeding 56 days. Only 50% received ORT. In multivariable analyses we only found ORT to be statistically significant predictor for progression-free survival (PFS) and overall survival (OS) (HR [95% CI] for non-ORT vs. ORT: 2.4 [1.2, 5.1], P = 0.014 for PFS and 2.2 [1.1, 4.6], P = 0.035 for OS). The 5-year PFS in patients who received ORT was better than that in patients who received non-ORT, 56% vs. 22% (95% CI: [36%, 72%] vs. [9%, 39%]). Patients who received ORT had a better 5-year OS as well (59% vs. 33%; 95% CI: [38%, 75%] vs. [16%, 51%]). Conclusion. Patients with locally advanced cervical cancer treated with weakly carboplatin or cisplatin, teletherapy, and low dose-dose rate brachytherapy have poorer outcomes when treatment duration is prolonged.

Adjuvant vaginal cuff brachytherapy for high-risk, early stage endometrial cancer.

PurposeTo report outcomes following adjuvant high-dose-rate vaginal brachytherapy (VBT) with or without chemotherapy for high-intermediate risk (HIR) and high-risk, early stage endometrial cancer as defined in Gynecologic Oncology Group trial 0249.Material and methodsFrom May 2000 to January 2014, 68 women with HIR and high-risk endometrial cancer underwent surgical staging followed by VBT. Median VBT dose was 21 Gy delivered in three fractions prescribed to 0.5 cm depth. Paclitaxel 175 mg/m2 and carboplatin area under the curve 6 was administered every 21 days in sequence with VBT. Actuarial survival estimates were calculated using the Kaplan-Meier method.ResultsPatient demographics included a median age of 66 years (range: 36-91) and stages IA (49%), IB (38%), and II (13%), respectively. Thirty-one (46%) patients had HIR disease with endometrioid histology, and 33 (48%) patients had serous or clear cell histology. Thirty-seven (54%) patients received a median 3 cycles (range: 3-6) of chemotherapy in addition to VBT, and 65 patients (96%) completed all prescribed therapy. During a median follow up of 33.1 months (range: 4.0-161.7), four patients have recurred, including one vaginal recurrence. The 3-year estimates of vaginal, pelvic, and distant recurrences were 1.9%, 2.4%, and 9.1%, respectively. The 3-year rates of disease-free and overall survival were 87.7% and 93.9%, respectively.ConclusionsEarly outcomes with adjuvant VBT with or without chemotherapy demonstrate high rates of vaginal and pelvic control for women with HIR disease. Early vaginal and pelvic relapses in high-risk patients suggest that pelvic external beam radiotherapy is warranted in this subgroup, but additional data from large phase III trials is warranted.

Low rate of lymphedema after extended pelvic lymphadenectomy followed by pelvic irradiation of node-positive prostate cancer

BackgroundThe aim of the present study was to evaluate the prevalence and severity of lower limb lymphedema after pelvic lymphadenectomy and radiotherapy to the pelvic lymph nodes in patients with prostate cancer.MethodsTwenty-six patients underwent combined treatment for high-risk node-positive prostate cancer at Skåne University Hospital between April 2008 and March 2011. The treatment consisted of extended pelvic lymphadenectomy followed by androgen deprivation therapy and radiotherapy. The pelvic lymphnodes, prostate and seminal vesicles were treated with external beam radiotherapy (EBRT) to an absorbed dose of 50 Gy followed by a brachytherapy (BT) boost of 2x10 Gy to the prostate only. Twenty-two patients accepted an invitation to a clinical examination with focus on lower limb swelling. The median time between the end of radiotherapy and examination was 2.2 years (range 1.2–4.1).ResultsSix patients (27%) experienced grade 1 lymphedema and two patients (9%) grade 2 while none had grade 3 or 4 according to the CTC Common Toxicity Criteria scale 4.0. Three patients required treatment with compression stockings.ConclusionBrachytherapy and pelvic EBRT have a low incidence of lymphedema (at median 2.2 y after treatment) in patients with high-risk node-positive prostate cancer that have undergone pelvic lymph node dissection.

Daily Low-Dose Cisplatin-Based Concurrent Chemoradiotherapy in Patients With Uterine Cervical Cancer With Emphasis on Elderly Patients

We evaluated the usefulness of daily low-dose cisplatin-based concurrent chemoradiotherapy (daily CCRT) in patients with cervical cancer with an emphasis on elderly patients. Between January 2003 and December 2008, a total of 65 patients with untreated stage IIA to IIIB cervical cancer were enrolled and 54 were selected for this nonrandomized prospective study. The daily CCRT comprised pelvic external beam radiotherapy (2 Gy/d × 25) with daily low-dose cisplatin (8.0 mg/m(2) per day) and either low- or high-dose rate intracavitary brachytherapy. The median age of the patients was 62 years (range, 29-85 years), and 21 patients (39%) were 70 years or older. The median follow-up period was 47 months (range, 4-107 months). Daily CCRT was successfully completed in 91% (49/54) of the patients. The mean total cisplatin dose was 191 mg/m (range, 128-224 mg/m(2)), and a neutropenia grade higher than 3 was observed in 24% of the patients. Of the 21 patients 70 years or older, 17 (81%) completed daily CCRT with acceptable toxicity. The 3-year overall survival (OS) rate for all the patients was 82.9%. No statistically significant differences in the OS rate and toxicity were observed between patients 70 years or older and those younger than 70 years. Daily CCRT showed acceptable toxicity and compliance, leading to the use of a high total dosage of cisplatin. The OS rate for daily CCRT was comparable to that for previously reported weekly CCRT. Daily CCRT could be an alternate choice for the CCRT treatment in elderly patients with cervical cancer.

Long-term Follow-up Results of a Multi-institutional Phase 2 Study of Concurrent Chemoradiation Therapy for Locally Advanced Cervical Cancer in East and Southeast Asia

To report the long-term survival and toxicity of a multi-institutional phase 2 study of concurrent chemoradiation therapy (CCRT) for locally advanced cervical cancer in east and southeast Asia. Ten institutions from 8 Asian countries participated in the study. Between April 2003 and March 2006, 120 patients (60 with bulky stage IIB and 60 with stage IIIB) were treated with CCRT. Radiation therapy consisted of pelvic external beam radiation therapy and either high-dose-rate or low-dose-rate intracavitary brachytherapy. Five cycles of weekly cisplatin (40 mg/m(2)) were administered during the course of radiation therapy. Treatment results were evaluated by the rates of local control, overall survival, and late toxicities. Median follow-up was 63.7 months, and the follow-up rate at 5 years was 98%. The 5-year local control and overall survival rates for all patients were 76.8% and 55.1%, respectively. The 5-year rates of major late toxicities of the rectum and bladder were 7.9% and 0%, respectively. The long-term results have suggested that CCRT is safe and effective for patients with locally advanced cervical cancer in east and southeast Asia. However, further efforts are needed to improve overall survival.

Postoperative external beam radiation therapy and concurrent cisplatin followed by carboplatin/paclitaxel for stage III (FIGO 2009) endometrial cancer

ObjectiveThe optimal adjuvant therapy in advanced endometrial cancer is controversial. One regimen is concurrent external beam pelvic irradiation (RT) and cisplatin, then carboplatin/paclitaxel. This study reports an institutional experience using this approach in stage III (FIGO 2009) endometrial cancer. MethodsPatients with stage III (FIGO 2009) endometrial cancer who underwent total hysterectomy and bilateral salpingo-oophorectomy at a single institution from 01/2004 to 12/2009 were identified retrospectively. Those treated with adjuvant RT/cisplatin, followed by carboplatin/paclitaxel comprised the study population. ResultsOf the 40 eligible patients, 7 (18%) were stage IIIA and 33 (82%) IIIC. Nineteen patients (48%) were ≥60years of age. Twenty-three (58%) had ≥50% myometrial invasion, 30 (75%) lymphovascular invasion, 11 (28%) cervical stromal invasion, and 5 (12%) positive peritoneal cytology. Histology was endometrioid in 32 (80%), serous in 6 (15%), and clear cell in 2 (5%). At a median follow-up of 49months, the 5-year freedom from relapse was 79% and overall survival 85%. The 5-year rate of vaginal recurrence was 3%, non-vaginal pelvic recurrence 3%, para-aortic recurrence 11%, peritoneal recurrence 5%, and other distant recurrence 11%. Thirty-one patients (78%) were able to complete the planned RT/cisplatin and 4cycles of carboplatin/paclitaxel. Acute grade 3 toxicity occurred in 10 patients (4 neutropenia, 2 anemia, 1 fatigue, 2 diarrhea). No late toxicity was grade ≥3. ConclusionThese favorable outcomes corroborate those of RTOG 9708. Until prospective data that compare adjuvant therapy regimens mature, concurrent chemoradiation should be strongly considered in stage III endometrial cancer.

A Randomized Comparison of Cisplatin and Oral Vinorelbine as Radiosensitizers in Aged or Comorbid Locally Advanced Cervical Cancer Patients

Chemoradiation with cisplatin is considered the standard of care for patients with locally advanced cervical cancer; however, cisplatin could be difficult to use in aged patients or patients with comorbidities such as diabetes mellitus and blood hypertension; hence, it is important to investigate nonplatinum drugs for radiosensitization. In addition, oral cytotoxics may overcome the drawbacks of intravenous infusions and could be of easier administration. In this small randomized trial, we tested cisplatin against oral vinorelbine as radiosensitizers in these patients. A total of 39 patients 65 years or older or diabetic and hypertensive patients of any age were randomized to cisplatin or oral vinorelbine at 40 mg/m² or 60 mg/m², respectively. Both drugs were administered weekly for 6 courses during pelvic external-beam radiotherapy and brachytherapy radiation. Efficacy and safety were assessed. Nineteen patients received oral vinorelbine, and 20 patients received cisplatin. The median cumulative dose to point A was 80.8 Gy for both groups, and the overall treatment time was 48 (42-54) and 50 (43-55) days for vinorelbine and cisplatin groups, respectively. Patients in both arms received a median of 5 applications of chemotherapy. Treatment was well tolerated in both arms. The most frequent toxicity in both arms was lymphopenia grades 2 and 3. At a median follow-up time of 16 months (4-19), there were no differences in either progression-free survival or overall survival between groups. Our results suggest that these patient populations can safely be treated with either cisplatin or navelbine as radiosensitizers; however, a larger randomized study is needed to demonstrate the noninferiority of oral vinorelbine as an easier and practical alternative for radiosensitization in cervical cancer.

High-dose-rate endorectal brachytherapy for locally advanced rectal cancer in previously irradiated patients

Preoperative high-dose-rate (HDR) endorectal brachytherapy is well tolerated among patients with locally advanced rectal cancer. However, these studies excluded patients who previously received pelvic radiation therapy (RT). Because a favorable toxicity profile has been published for HDR endorectal brachytherapy, we evaluated this technique in patients who have previously received pelvic irradiation. We included patients who had received pelvic irradiation for a previous pelvic malignancy and later received preoperative HDR endorectal brachytherapy for rectal cancer. Brachytherapy was delivered to a total dose of 26 Gy in 4 consecutive daily 6.5 Gy fractions. We evaluated 10 patients who previously received pelvic external beam radiation therapy (EBRT) alone (n=6), EBRT and brachytherapy (n=2), or brachytherapy alone (n=2). The median interval between the initial course of RT and endorectal brachytherapy was approximately 11 years (range, 1-19 years). Two patients experienced a complete pathologic response while 1 patient had a near complete pathologic response. No acute grade ≥3 toxicity was observed. No intraoperative or postoperative surgical complications were observed. Preoperative HDR endorectal brachytherapy is an alternative to EBRT for patients with locally advanced rectal cancer who have previously received pelvic RT.

Curiethérapie du canal anal

Low dose-rate brachytherapy as a boost after concomitant chemoradiation therapy is a standard of care for locally advanced anal carcinoma, providing a rigorous selection taking into account the initial staging and tumor response to external beam radiotherapy. Local control is likely to be superior when the boost is performed with brachytherapy than with external beam radiotherapy. The several steps of the brachytherapy procedure are described. The standard treatment scheme is a concomitant chemoradiation therapy, including 45Gy (1,8Gy×5) pelvic external beam radiotherapy and two courses of 5-fluorouracil and mitomycin-C, followed by a 15Gy brachytherapy boost with a gap limited to 2 to 3weeks. Higher irradiation dose for the most advanced cases has not yet demonstrated a therapeutic gain in terms of colostomy free survival. Exclusive brachytherapy for in-situ carcinoma or invasive carcinoma less than 10mm is not recommended due to a high risk of local recurrence. Pulsed dose rate brachytherapy is an alternative to low dose rate brachytherapy (iridium wires) providing the respect of the recommended dose rate (0.5 to 1Gy/hour). High dose rate brachytherapy is still under evaluation.

Real-Time Integration of MR Imaging for Prostate High-Dose-Rate Brachytherapy Using 3D Slicer

Purpose: To report acute (!3 months) and late (O6 months) genitourinary (GU), and gastrointestinal (GI) toxicities, and erectile dysfunction (ED) in patients treated with inverse-planned selective HDR brachytherapy boost to the dominant intraprostatic lesion (DIL) defined with magnetic resonance spectroscopy (MRS). Materials and Methods: We analyzed data prospectively collected from 20 patients treated in 2010-2011 for localized intermediate-risk prostate adenocarcinoma. All patients had an MRI/MRS to define the DIL before treatment. Afterward, they received external beam pelvic radiation (40-44 Gy in 20-22 fractions) followed by HDR (Ir) brachytherapy boost. The boost dose was 15 Gy in one fraction to the whole gland with simultaneous 3 Gy selective boost to the DIL (total of 18 Gy to DIL). All patients were planned with inverse-planning simulated annealing (IPSA). Thereafter, IPSS, International Index of Erectile Dysfunction-5 (IIEF5) and GI toxicities questionnaires were completed prospectively every three months at a followup visits. Results: The median age was 65.5 years. The median followup was 23.6 months. Fifty-five percent of the patients had clinical stage T1c, 25 % T2a, 15% T2b and 5% T2c. All patients were Gleason score (GS) 7. The pretreatment PSA was 0-5 ng/mL in 30%, 5-10 ng/mL in 60% and 10-15 ng/mL in 10% of the patients, respectively. No patients received antiandrogen therapy. The average IPSS at baseline and 1, 4 and 12 months was 6.57/35, 10.94/35, 7.32/35 and 8.47/35, respectively. At 3 months we observed a decrease of IIEF5 score from baseline of -4.45 (þ/-0.22) and -3.31 (þ/-0.39) atO6 months. At 3 months 50% of patients presented no GI symptoms and 50% occasional GI symptoms. No patients presented severe GI toxicityO6 months. Conclusions: Selective DIL image-guided (MRS) HDR brachytherapy boost in intermediate-risk cancer, is feasible with acceptable acute and late GU and GI toxicity at the price of decreasing IIEF5 score. Longer followup is necessary to evaluate tumor control.

A prospective randomized controlled trial to study the role of sulfasalazine in prevention of acute gastrointestinal toxicity associated with concurrent chemoradiation in carcinoma cervix

Background: The primary aim of the study was to evaluate the effectiveness of sulfasalazine in reducing the incidence of acute radiation-induced enteritis in carcinoma cervix patients receiving pelvic external beam radiotherapy along with concurrent cisplatin-based chemotherapy. Materials and Methods: Between November 2011 and July 2012 a total of 98 patients of locoregionally advanced carcinoma of cervix (49 each in study and control arms) were enrolled in this study. Patients in both the arms were treated with whole pelvis external beam radiotherapy with total dose of 50 Gy in conventional fractionation. Along with this inj. cisplatin was given concurrently at the dose of 40 mg/m 2 of body surface area every week during radiation for 5 weeks. Concurrent chemoradiation was followed by brachytherapy after a gap of 2 weeks. Patients in the study arm also received tablet sulfasalazine 1,000 mg orally twice daily from the day of starting of radiotherapy to 1 week after completion of treatment. Weekly follow-up of all patients to assess acute toxicities was done using common toxicity criteria version 4.0 (CTC v4.0) toxicity scores. Data analysis was carried out by SPSS version 20.0 software. Results: Incidence of grade II or higher grade, lower gastrointestinal toxicity was 19.14% (09/47) in study arm and 41.66% (20/48) in control arm which was statistically significant (P = 0.017). Conclusion: The study shows that sulfasalazine can significantly reduce the acute radiation-induced diarrhea (ARID) in patients undergoing whole pelvis external beam radiotherapy for carcinoma cervix. The drug is safe, cheap, and readily available.

Multiple myeloma with pleural involvement after pelvic radiotherapy for endometrial carcinoma

Although ionizing radiation is strongest factor linked to multiple myeloma, increased myeloma risk has not been fully explained after pelvic radiation. Pleural involvement of MM is also rare. We present a MM case with pleural involvement as an unusual presentation diagnosed in fifth years of pelvic radiotherapy. A sixty-two-year-old woman with dyspnea and a mass in forehead was admitted to our clinic. Before five year, the patient had received pelvic external beam radiotherapy (RT) with dose of 40 Gy for endometrial adenocarcinoma. PET/CT scan detected FDG uptakes in frontal bone, right pleura, and sacrum. Lambda light chain type multiple myeloma with pleural involvement was diagnosed with histopathological examinations of frontal bone mass, bone marrow, and pleural fluid and with serum/urine electroforesis. The patient died in second course of VAD chemotherapy. Although relation between increased myeloma risk and pelvic radiation is not clear and pleural involvement is rare, multiple myeloma should be included to the differential diagnosis in patients received pelvic radiotherapy or in unexplained pleural effusion.

The role of surgery in locally advanced carcinoma of cervix after sub-optimal chemoradiation: Indian scenario

Background:Standard treatment of advanced cervical cancer is concurrent chemoradiation. Radical radiotherapy for carcinoma cervix includes pelvic external beam radiotherapy (EBRT) with the concomitant platinum based chemotherapy followed by intracavitary brachytherapy (ICBT) to boost central disease. Management of patients who are suboptimally treated, especially, after unsuccessful ICBT insertion is not well-defined. This study explores the role of hysterectomy in these patients.Materials and Methods:From January 2006 to December 2011, 38 patients with locally advanced cervical cancer, in whom ICBT insertion was unsuccessful, were analyzed retrospectively. Operable patients with no parametrial involvement underwent hysterectomy and outcomes (recurrence free and overall survival) were noted.Results:The major complications in post operative period were wound infection, paralytic ileus and bladder atony all of which were conservatively managed with no mortality. At median follow-up of 36 months (range 12-60 months) there was no recurrence in patients with stage 1B2 and stage IIA, 25 out of 38 (65.8%) were event free and the overall survival was 71%.Conclusion:Many patients in Indian scenario receive suboptimal therapy in locally advanced cervical cancer. EBRT with chemotherapy followed by type 1 extra-fascial hysterectomy can be a good alternative for these patients.

External Beam Therapy in a Four-Field Box Technique with Paclitaxel versus a Two-Field Technique with Cisplatin in Locally Advanced Carcinoma Cervix: A Phase II Monocentric Trial

Introduction. External beam pelvic radiotherapy with cisplatin and brachytherapy is the standard of care for patients with advanced cervical malignancy. This study was aimed at evaluating the toxicity of a two-field radiotherapy with cisplatin and brachytherapy compared to a four-field box technique with paclitaxel and brachytherapy for stages IIB/IIIB cervical cancer. The differences in response to the overall treatment were also examined. Methods. 35 patients were enrolled in this phase II prospective randomized trial conducted from February 2006 to February 2007. In arm I, up to 40 Gy in 20 fractions followed by 10 Gy in 5 fractions in split field with cisplatin 40 mg/M2 and, in arm II, 50 Gy in 25 fractions with paclitaxel 50 mg/M2 were given. Results. Toxicity in genitourinary, lower gastrointestinal, and hematological tissues was significantly higher in arm I. The duration of concurrent chemoradiotherapy in either arm was similar. The overall treatment time was less in arm II. No statistically significant difference in the objective response was observed between arms. Conclusion. Two-field radiotherapy with cisplatin is a tolerable regime but more toxic than four-field box radiotherapy with paclitaxel. The major setbacks are that a radiotherapy technique as well as chemotherapy is different; hence, toxicity and outcome of treatment should be viewed as a collective response of the whole treatment regimen and the small sample size.

Radiation Therapy in the Management of Carcinosarcoma of the Uterus

Radiation Therapy in the Management of Carcinosarcoma of the Uterus

Adjuvant Radiation Therapy for Patients With Type 2 Endometrial Carcinoma: Impact on Tumor Recurrence and Survival

The optimal adjuvant treatment of type II endometrial carcinoma after hysterectomy remains controversial. The objective of this study is to determine the effect of adjuvant radiation therapy (RT) on recurrence-free survival (RFS), disease-specific survival (DSS) and overall survival (OS) in patients with early stage type II endometrial carcinoma. In this IRB-approved study, our prospectively-maintained database of 1450 patients with endometrial cancer was reviewed. Seventy-nine surgically staged patients with 2009 FIGO stage I-II serous and clear cell carcinoma were treated from 1989-2010. All patients underwent total abdominal hysterectomy, oophorectomy, pelvic and paraortic lymph node evaluation and peritoneal cytology examination. The medical records were reviewed, and patient demographics, pathologic features and treatment-related factors were analyzed. The impact of adjuvant RT, on RFS, DSS and OS was studied. Following univariate analysis, multivariate modeling was done using multiple Cox proportional hazards analysis. Seventy-nine patients were analyzed. The median age of the study cohort was 65 years and median follow-up of 44.1 months. Thirty-nine patients (49%) received adjuvant RT (with pelvic external beam RT in 9 patients, vaginal cuff brachytherapy in 8 patients and a combination in 22 patients). Thirty-four (43%) patients received platinum-based chemotherapy. The 5-year RFS was significantly improved in patients who received RT (84% vs 58%, p=0.002). Similarly, 5-year DSS was significantly improved in patients who received RT (87% vs 58% p=0.023) with a trend towards improved 5-year OS (74% vs 56% p=0.088). On multivariate analysis, lack of angiolymphatic invasion (p<0.001 and p<0.001), adjuvant RT (p<0.001 and p=0.004) and lack of lower uterine segment involvement (p=0.007 and p=0.009) were independent predictors of improved RFS and DSS, respectively. In the current study for surgically staged FIGO I-II patients with type II endometrial carcinoma, adjuvant therapy with RT resulted in a significant improvement in recurrence-free and disease-specific survival. These results support the need for a prospective trial evaluating the role or RT in this group of patients.

1002P - The Role of Intravaginal Brachytherapy in Surgically-Staged 1988 Figo Stage IC Grade 3 Endometrial Cancer

ABSTRACT Purpose/objectives Patients with 1988 International Federation of Gynecology and Obstetrics (FIGO) Stage IC grade 3 (ICgr3) endometrial cancer (EC) were excluded or underrepresented on practice-defining intermediate-risk EC trials due to relatively high rates of occult nodal and/or distant metastasis. Adjuvant therapy recommendations in this population vary widely, but standard practice is to offer adjuvant pelvic external beam radiotherapy (EBRT) +/- chemotherapy. We report our single-institution's experience using adjuvant high-dose rate (HDR) vaginal brachytherapy (VBT) alone +/- chemotherapy for patients with surgically-staged 1988 FIGO ICgr3 EC. Methods From 1998 to 2011, 47 women with FIGO ICgr3 EC underwent TAH/BSO with pelvic/paraaortic lymph node dissection (median nodes evaluated, 47; range, 5-88) followed by VBT. All VBT was performed using a multi-channel cylinder, treating the entire vaginal mucosa from the cuff to within 1-2 cm of urethral meatus to 21 Gy in 3 fractions. No patient received pelvic EBRT. Twenty-one patients (45%) also received 3 to 6 cycles of adjuvant platinum-based chemotherapy. Results At a median follow-up of 30 months (range, 1 to 127 months), 3 patients had experienced a vaginal relapse (VR), and the 3-year Kaplan-Meier (KM) estimate of VR was 8%. Rates of isolated pelvic (PR), locoregional (LRR, VR + PR), and distant relapse (DR) were similarly low, with 3-year estimates of 3, 10, and 14%, respectively. Estimates for 3-year disease-free (DFS) and overall survival (OS) were 87 and 80%, respectively. On univariate analysis, administration of chemotherapy significantly correlated with improved DFS (p = 0.03). Conclusions Rates of isolated vaginal and pelvic relapse after VBT +/- chemotherapy in these women with surgically-staged 1988 FIGO ICgr3 EC were comparable to those seen with pelvic EBRT, implying additional radiotherapy is likely unnecessary. Adjuvant platinum-based chemotherapy was associated with improved disease-free survival. While VBT reduced the rate of pelvic relapse, the vagina remained the most common pelvic site of recurrence. Disclosure All authors have declared no conflicts of interest.

External Pelvic and Vaginal Irradiation Versus Vaginal Irradiation Alone as Postoperative Therapy in Medium-Risk Endometrial Carcinoma: A Prospective, Randomized Study—Quality-of-Life Analysis

A combination of vaginal brachytherapy and external beam radiotherapy was compared with brachytherapy alone in medium-risk endometrial carcinomas. Quality-of-life analysis is an important part of a randomized study to find out the optimal adjuvant treatment for this group of patients. To evaluate the value of adjuvant external beam pelvic radiotherapy in adjunct to vaginal brachytherapy in medium-risk endometrial carcinoma. Quality-of-life evaluation is the main topic of this report. A consecutive series of 527 evaluable patients were included in this randomized trial. Median follow-up for patients alive was 62 months. The primary study end points were locoregional recurrences and overall survival. Secondary end points were recurrence-free survival, toxicity, and quality-of-life. European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-OV28 modules were used to evaluate global health status, functional scales, and symptom scales. Five-year locoregional relapse rates were 1.5% after external beam (ERT) plus vaginal irradiation (VBT) and 5% after vaginal irradiation alone (P = 0.013), and 5-year overall survival (OS) rates were 89% and 90%, respectively. External beam radiotherapy was associated with a higher rate of adverse effects from the intestine and the bladder, and quality-of-life parameters deteriorated at the end of radiotherapy but recovered to normal levels within a few months. There was a significant difference in favor of VBT alone with regard to adverse effects of the bowel and urinary tract, and quality-of-life. Despite a significant locoregional control benefit with combined radiotherapy, no survival improvement was recorded; but increased late toxicity from the intestine and the bladder. External beam irradiation decreased global health status during and after treatment, and 3 functional scale items (physical, role, and social). Six of 11 symptom items showed a pattern favoring vaginal brachytherapy alone.

Impact of concurrent chemotherapy on definitive radiotherapy for women with FIGO IIIb cervical cancer

The purpose of this retrospective study is to investigate the impact of concurrent chemotherapy on definitive radiotherapy for the International Federation of Gynecology and Obstetrics (FIGO) IIIb cervical cancer. Between 2000 and 2009, 131 women with FIGO IIIb cervical cancer were treated by definitive radiotherapy (i.e. whole pelvic external beam radiotherapy for 40–60 Gy in 20–30 fractions with or without center shielding and concomitant high-dose rate intracavitary brachytherapy with 192-iridium remote after loading system for 6 Gy to point A of the Manchester method). The concurrent chemotherapy regimen was cisplatin (40 mg/m2/week). After a median follow-up period of 44.0 months (range 4.2–114.9 months) and 62.1 months for live patients, the five-year overall survival (OS), loco-regional control (LRC) and distant metastasis-free survival (DMFS) rates were 52.4, 80.1 and 59.9%, respectively. Univariate and multivariate analyses revealed that lack of concurrent chemotherapy was the most significant factor leading to poor prognosis for OS (HR = 2.53; 95% CI 1.44–4.47; P = 0.001) and DMFS (HR = 2.53; 95% CI 1.39–4.61; P = 0.002), but not for LRC (HR = 1.57; 95% CI 0.64–3.88; P = 0.322). The cumulative incidence rates of late rectal complications after definitive radiotherapy were not significantly different with or without concurrent chemotherapy (any grade at five years 23.9 vs 21.7%; P = 0.669). In conclusion, concurrent chemotherapy is valuable in definitive radiotherapy for Japanese women with FIGO IIIb cervical cancer.

Phase II study of preoperative radiation with concurrent capecitabine, oxaliplatin, and bevacizumab followed by surgery and postoperative 5-FU, leucovorin, oxaliplatin (FOLFOX), and bevacizumab in patients with locally advanced rectal cancer: A trial of the Eastern Cooperative Oncology Group (E3204).

3605 Background: Oxaliplatin and bevacizumab potentiate the antitumor activity of fluoroyprimidines and radiotherapy in preclinical and clinical studies of colorectal cancer. This phase II trial evaluated the efficacy of the preoperative combination of capecitabine, oxaliplatin, and bevacizumab with radiotherapy in rectal cancer. Methods: Eligibility: resectable T3/T4 adenocarcinoma of the rectum ≤ 12 cm. from anal verge. Preoperative treatment was capecitabine (825 mg/m² bid M-F), oxaliplatin (50 mg/m² weekly), bevacizumab (5 mg/kg D1,15,29), and pelvic external beam radiotherapy (50.4 Gy/28 fractions). Surgery was performed within 6-8 weeks. Within 12 weeks of surgery, patients received 12 cycles of FOLFOX + bevacizumab (5 mg/kg) Q2 weeks. Pathologic complete response (path CR) was the primary endpoint. Secondary endpoints included resection rate and toxicity. Results: Fifty-seven patients (pts) enrolled from 7/06 to 5/10 and 54 were eligible. Clinical staging: T3/4 (50/4), NX0/1/2 (2/16/31/5). Most common grade 3/4 non-hematologic toxicities during treatment were rectal pain (9), fatigue (8), and diarrhea (7). Two patients died of aspiration. Nine pts had early postsurgical complications (9 wound infections, 6 dehiscence, 1 abscess) and 23 had late surgical complications (23 non-healing wounds, 12 dehiscence, 5 bowel obstruction/ileus, 2 abscess). Pathologic staging: T0/1/2/3 (11/3/15/19), N0/1/2 (32/10/7). Nine pts had path CRs (17%, 90% CI:[9%-27%]. Surgery was LAR (38) and APR (11). Twenty-two pts did not receive postoperative chemotherapy (39%), 16 due to adverse events. Five local recurrences have been reported. RFS and OS data are immature. Conclusions: The addition of oxaliplatin and bevacizumab to capecitabine and radiotherapy for locally advanced rectal cancer resulted in downstaging for the majority of pts but did not improve the pathologic complete response rate compared to historical controls. The combination resulted in significant early and late postsurgical complications.