Who would be the winner? A prognostic nomogram for predicting the benefit of postoperative radiotherapy ± chemotherapy in patients with locally advanced gastric cancer: TROD-02-01 study.

OBJECTIVES: We aimed to develop a basic, easily applicable nomogram to improve the survival prediction of the patients with stage II/III gastric cancer (GC) and to select the best candidate for postoperative radiotherapy (RT). METHODS: In this multicentric trial, we retrospectively evaluated the data of 1597 patients with stage II/III GC after curative gastrectomy followed by postoperative RT ± chemotherapy (CT). Patients were divided into a training set (n = 1307) and an external validation set (n = 290). Nomograms were created based on independent predictors identified by Cox regression analysis in the training set. The consistency index (C-index) and the calibration curve were used to evaluate the discriminative ability and accuracy of the nomogram. A nomogram was created based on the predictive model and the identified prognostic factors to predict 5-year cancer-specific survival (CSS) and progression-free survival (PFS). RESULTS: The multivariate Cox model recognized lymph node (LN) involvement status, lymphatic dissection (LD) width, and metastatic LN ratio as covariates associated with CSS. Depth of invasion, LN involvement status, LD width, metastatic LN ratio, and lymphovascular invasion were the factors associated with PFS. Calibration of the nomogram predicted both CSS and PFS corresponding closely with the actual results. In our validation set, discrimination was good (C-index, 0.76), and the predicted survival was within a 10% margin of ideal nomogram. CONCLUSIONS: In our relatively large cohort, we created and validated both CSS and PFS nomograms that could be useful for underdeveloped or developing countries rather than Korea and Japan, where the D2 gastrectomy is routinely performed. This could serve as a true map for oncologists who must make decisions without an experienced surgeon and a multidisciplinary tumor board.

Multi-institutional analysis of cervical esophageal carcinoma patients treated with definitive chemoradiotherapy: TROD 01-005 study.

The aim of this study was to examine the prognostic factors and treatment outcomes of cervical esophageal carcinoma (CEC) patients who underwent definitive chemoradiotherapy (CRT). The clinical data of 175 biopsy-confirmed CEC patients treated with definitive CRT between April 2005 and September 2021 were retrospectively analyzed. The prognostic factors predicting overall survival (OS), progression-free survival (PFS), and local recurrence-free survival (LRFS) were assessed in uni- and multivariable analyses. The median age of the entire cohort was 56 years (range: 26-87 years). All patients received definitive radiotherapy with a median total dose of 60 Gy, and 52% of the patients received cisplatin-based concurrent chemotherapy. The 2-year OS, PFS, and LRFS rates were 58.8%, 46.9%, and 52.4%, respectively, with a median follow-up duration of 41.6 months. Patients' performance status, clinical nodal stage, tumor size, and treatment response were significant prognostic factors for OS, PFS, and LRFS in univariate analysis. Non-complete treatment response was an independent predictor for poor OS (HR = 4.41, 95% CI, 2.78-7.00, p < 0.001) and PFS (HR = 4.28, 95% CI, 2.79-6.58, p < 0.001), whereas poor performance score was a predictor for worse LRFS (HR = 1.83, 95% CI, 1.12-2.98, p = 0.02) in multivariable analysis. Fifty-two patients (29.7%) experienced grade II or higher toxicity. In this multicenter study, we demonstrated that definitive CRT is a safe and effective treatment for patients with CEC. Higher radiation doses were found to have no effect on treatment outcomes, but a better response to treatment and a better patient performance status did.

Using deep learning approaches for coloring silicone maxillofacial prostheses: A comparison of two approaches.

Aim: This study aimed to compare the performance of two deep learning algorithms, attention-based gated recurrent unit (GRU), and the artificial neural networks (ANNs) algorithm for coloring silicone maxillofacial prostheses. Settings and Design: This was an in vitro study. Materials and Methods: A total of 21 silicone samples in different colors were produced with four pigments (white, yellow, red, and blue). The color of the samples was measured with a spectrophotometer, then the LFNx01, aFNx01, and bFNx01 values were recorded. The relationship between the LFNx01, aFNx01, and bFNx01 values of each sample and the amount of each pigment in the compound of the same sample was used as the training dataset, entered into each algorithm, and the prediction models were obtained. While generating the prediction model for each sample, the data of the corresponding sample assigned as the target color were excluded. LFNx01, aFNx01, and bFNx01 values of each target sample were entered into the obtained models separately, and recipes indicating the ratios for mixing the four pigments were predicted. The mean absolute error (MAE) and root mean square error (RMSE) values between the original recipe used in the production of each silicone and the recipe created by both prediction models for the same silicone were calculated. Statistical Analysis Used: Data were analyzed with the Student t-test (α=0.05). Results: The mean RMSE values and MAE values for the ANN algorithm (0.029 ± 0.0152 and 0.045 ± 0.0235, respectively) were found significantly higher than the attention-based GRU model (0.001 ± 0.0005 and 0.002 ± 0.0008, respectively) (P < 0.001). Conclusions: Attention-based GRU model provided better performance than the ANN algorithm with respect to the MAE and RMSE values.

Improving locoregional outcome in high-intermediate-risk and high-risk stage I endometrial cancer with surgical staging followed by brachytherapy.

PURPOSE: This study aims to assess the locoregional efficacy of postoperative vaginal brachytherapy (VBT) alone in patients undergoing surgical staging for early-stage high-intermediate-risk (HIR) and high-risk (HR) endometrial cancer. MATERIALS AND METHODS: One hundred and four patients with early-stage HIR and HR endometrial cancer who underwent surgical staging were treated with adjuvant VBT alone. The patients with stage Ib, grade I-III, stage Ia, grade III, lower uterine segment involvement, and lymphovascular invasion (LVI) were included to study. RESULTS: The 5- and 10-year overall survival (OS) rates were 87% and 76%, respectively. The 5- and 10-year DFS rates were 86% and 86%, respectively. Among the patients, 92% had endometrioid adenocarcinoma, 2% had undifferentiated carcinoma, 2% had serous papillary carcinoma, and 4% had clear-cell carcinoma. Of the patients, 63% had stage Ib disease, while 37% had stage Ia disease. None of the patients had vaginal or pelvic lymph node recurrence, whereas two had para-aortic lymph node metastasis, one had surgical scar recurrence, one had para-aortic lymph node and brain metastasis, and one had lung metastasis. The presence of lymphatic invasion was found to be a statistically significant prognostic factor for increased distant metastasis rates (p = 0.020). Lymphatic invasion was also regarded as an independent prognostic factor for metastasis-free survival (p = 0.044). CONCLUSION: Our study results suggest that postoperative VBT alone is an effective and safe treatment modality with low complication in patients undergoing surgical staging for HIR and HR endometrial cancer.

Visual and instrumental color evaluation of computerized color matching system for color reproduction of maxillofacial prostheses.

STATEMENT OF PROBLEM: A commercially available computerized color matching system (e-Skin) has been introduced for maxillofacial prostheses. However, studies that have tested its ability to produce an acceptable color match for skin color are lacking. PURPOSE: The purpose of this clinical study was to determine the color match acceptability of light and dark skin silicone replicas fabricated with the use of the computerized color matching system. MATERIAL AND METHODS: Fifteen participants with light skin and 15 participants with dark skin were recruited through personal invitation. These 30 participants (aged around 20 years) voluntarily consented to forearm skin color measurements with a spectrophotometer and a spectrocolorimeter integrated in a computerized color matching system. Silicone skin replicas for each participant were produced from the color formulations provided by the online calculator tool of the system according to the manufacturers' recommendations. The color difference between initial skin color measurements with the spectrophotometer and skin replica color measurements with the spectrophotometer for all participants was calculated by using both the CIELab (ΔE∗ab) and CIEDE2000 (ΔE00) color difference formulas. To compare the instrumental and visual evaluation of color match, 3 observers (a maxillofacial prosthodontist, a prosthodontist, and a postgraduate student) visually evaluated and rated the color match of each silicone replica on a 5-point scale. Statistical analyses were performed by using the Student t, Mann Whitney U, and chi-square tests (α=.05). RESULTS: No significant differences were detected between the light and dark skin groups in terms of the ΔE∗ab and ΔE00 values obtained between the first skin color measurements and their silicone replica color measurements (P=.573, P=.338, respectively). However, a significant difference was found between light and dark skin groups for the ΔL and Δa values obtained from the same measurements (P=.031, P=.017, respectively). L∗, a∗, and b∗ values of light skin were significantly higher than those of their silicone replications (P=.008, P=.033, P=.046, respectively). Color match ratings of observers did not significantly differ when comparing the ratings of light skin replicas to ratings of dark skin replicas. CONCLUSIONS: The e-Skin system provided skin replicas that matched the skin color within clinically acceptable thresholds and with ratings of at least "good" by experienced dental clinicians.

Treatment outcomes of metastasis-directed treatment using 68Ga-PSMA-PET/CT for oligometastatic or oligorecurrent prostate cancer: Turkish Society for Radiation Oncology group study (TROD 09-002).

PURPOSE: The aim of this study was to evaluate the outcomes of 68Ga prostate-specific membrane antigen (68Ga-PSMA) positron-emission tomography (PET)/CT-based metastasis-directed treatment (MDT) for oligometastatic prostate cancer (PC). METHODS: In this multi-institutional study, clinical data of 176 PC patients with 353 lesions receiving MDT between 2014 and 2019 were retrospectively evaluated. All patients had biopsy proven PC with ≤5 metastases detected with 68Ga-PSMA-PET/CT. MDT was delivered with conventional fractionation or stereotactic body radiotherapy (SBRT) techniques. CTCAE v4.0 was used for acute and RTOG/EORTC Late Radiation Morbidity Scoring Schema was used for late toxicity evaluation. RESULTS: At the time of MDT, 59 patients (33.5%) had synchronous and 117 patients (66.5%) had metachronous metastases. Median number of metastases was one and the MDT technique was SBRT in 73.3% patients. The 2­year overall survival (OS) and progression-free survival (PFS) rates were 87.6% and 63.1%, respectively. With a median follow-up of 22.9 months, 9 patients had local recurrence at the irradiated site. The 2­year local control rate at the treated oligometastatic site per patient was 93.2%. In multivariate analysis, an increased number of oligometastases and untreated primary PC were negative predictors for OS; advanced clinical tumor stage, untreated primary PC, BED3 value of ≤108 Gy, and MDT with conventional fractionation were negative predictors for PFS. No patient experienced grade ≥3 acute toxicity, but one patient had a late grade 3 toxicity of compression fracture after spinal SBRT. CONCLUSION: 68Ga-PSMA-PET/CT-based MDT is an efficient and safe treatment for oligometastatic PC patients. Proper patient selection might improve treatment outcomes.

Effects of glazing methods on the optical and surface properties of silicate ceramics.

PURPOSE: This study aims to evaluate the effect of different glazing methods on translucency parameter (TP), contrast ratio (CR), opalescence parameter (OP), surface roughness (Ra) and topography of the silicate ceramics. METHODS: Seventy specimens (10×10×1mm) were fabricated from lithium disilicate (IPS e.max CAD, abbreviated as E) and zirconia-reinforced lithium silicate (Vita Suprinity, abbreviated as VS) ceramics and divided into 7 subgroups (n=10) according to the polishing and glazing procedures: (1) mechanical polishing before-crystallization (m-BC), (2) mechanical polishing after-crystallization (m-AC), (3) glaze powder/liquid after-crystallization (pl-AC), (4) glaze-paste before-crystallization (gp-BC), (5) glaze-paste after-crystallization (gp-AC), (6) glaze-spray before-crystallization (gs-BC), (7) glaze-spray after-crystallization (gs-AC). Color and Ra measurements were performed. CIEL*a*b* and CIEXYZ parameters were recorded and TP, CR, and OP values were calculated. Data were analyzed using two-way ANOVA and Tukey HSD tests (α=0.05). RESULTS: In E groups, the highest Ra value was found in gs-AC (1.66±0.14µm) while the lowest value was found in pl-AC (0.68±0.08µm). In VS groups, the highest Ra value was found in gp-BC (1.64±0.25µm) while the lowest value was found in m-AC (0.77±0.06µm) (p<0.05). The mean TP value of E (17.62±0.73) was found to be higher than VS (15.37±1.16). The CR (0.72±0.030) and OP (12.06±0.74) values of VS were found higher than CR (0.57±0.02) and OP (6.72±0.40) values of E. CONCLUSIONS: Zirconia-reinforced silicate ceramics have higher opalescence and lower translucency values than lithium disilicate ceramics. Increase in surface roughness reduces translucency. Glaze powder/liquid after-crystallization is the most effective way to reduce surface roughness of lithium disilicate ceramics while that is mechanical polishing after-crystallization for zirconia-reinforced silicate ceramics.

Effects of accelerated artificial aging on the translucency and color stability of monolithic ceramics with different surface treatments.

STATEMENT OF PROBLEM: Different surface finishing procedures can be applied to monolithic restorations. However, information is limited regarding the long-term performance of these procedures. PURPOSE: The purpose of this in vitro study was to evaluate the effect of aging on the translucency and color stability of monolithic ceramics with different surface finishing procedures. MATERIAL AND METHODS: Disk-shaped (14×1.5 mm) specimens of monolithic zirconia (Zirkonzahn Prettau [ZZ]) and lithium disilicate glass-ceramic (IPS e.max Press [IPS]) were fabricated. The specimens were divided into 3 subgroups according to the surface treatments (n=9, G: glazing, R: rubber polishing system, and P: rubber polishing system followed by polishing paste). Color measurements were made by using a spectrophotometer before and after an ultraviolet aging process. L*, a*, and b* parameters were recorded. ΔE and translucency parameter (TP) values were calculated. One specimen from each subgroup was examined by scanning electron microscopy (×30 000). The data were statistically analyzed using the Mann-Whitney U, Kruskal-Wallis, and post hoc tests (α=.05). RESULTS: ΔE values of group ZZ (5.03) exceeded the clinically acceptable level (3.5); however, the color change was not clinically perceptible for IPS (0.41). The ΔE value of the subgroup P was found to be higher than that of the others for ZZ (P<.001). The ΔE value was not affected by the surface treatment for IPS. Group IPS showed significantly higher translucency than the ZZ group (P<.001). TP values were not affected by the surface treatment in either material and decreased after aging. However, changes in the TP values were too slight to be clinically perceptible. CONCLUSIONS: Lithium disilicate ceramic was found to be more esthetic than monolithic zirconia ceramic in terms of color stability and translucency.

Multidisciplinary rehabilitation of eosinophilic granuloma with bone graft surgery and a modified implant-supported hybrid prosthesis: A case report with a 6-year follow-up.

Eosinophilic granuloma is the most common form of Langerhans cell histiocytosis and corresponds with bone lesions characterized by pain, rapid growth, and high tendency of recurrence after inadequate curettage. It is a rare disease that is difficult to diagnose clinically and radiographically because it mimics other odontogenic cysts and tumors. In this report, the reconstruction of an osseous defect with an iliac graft and a modified implant-supported hybrid prosthesis after surgical excision of an eosinophilic granuloma in the mandible of a 27-year-old male patient was described. The patient was satisfied with the functional and esthetic results of the implant-supported restoration and a 6-year follow-up showed no sign of recurrence.

An unusual case of adult-onset multi-systemic Langerhans cell histiocytosis with perianal and incident thyroid involvement.

SUMMARY: Langerhans cell histiocytosis (LCH) is a rare sporadic disease characterized by histiocytic neoplastic infiltration of various organ systems and a wide spectrum of clinical manifestations, ranging from benign and self-limiting to lethal. Herein, we report a rare case of adult-onset multi-systemic LCH in a 36-year-old male patient with an initial perianal presentation and incidental finding of subsequent thyroid gland involvement in the follow-up period. The patient with a history of perianal LCH treated with surgical excision and local radiotherapy was referred to our Endocrinology Department upon detection of hypermetabolic nodular lesions in the left lateral lobe of thyroid gland on positron emission tomography-computed tomography (PET/CT) scan in the nineth month of follow-up. Current evaluation revealed euthyroid status, a hypoechoic solid lesion of 13 × 9 mm in size with irregular borders in the left thyroid lobe on thyroid USG and cytologic assessment of thyroid nodule. The patient was diagnosed with suspected, oncocytic lesion, Hashimoto thyroiditis or LCH. The patient underwent total thyroidectomy and pathological assessment confirmed the diagnosis of Langerhans cell histiocytosis. Assessments in the sixth month of postoperative follow-up revealed euthyroid status with no thyroid tissue remnants or pathological lymph node on thyroid USG. In view of the multifocal lesions indicating multi-system disease, a systemic chemotherapy protocol with combination of prednisone (PRED) and vinblastine (VBL) has been planned by the hematology department. LEARNING POINTS: Langerhans cell histiocytosis (LCH) shows a wide clinical spectrum and prognosis that ranges from benign and self-limiting single-system disease (with single or multifocal lesions) to a potentially lethal multi-system disease with severe organ dysfunction and death in some cases.It has been stated that the diagnosis is often delayed in perianal LCH unless LCH is specifically considered in the etiology, despite the fact that mucosal involvement may precede systemic involvement.Our findings support the statement that most of patients with LCH were PET positive at the time of initial diagnosis, while also emphasize the inclusion of this imaging modality as a part of the diagnostic workflow as well as in the setting of treatment response evaluation among adult LCH patients.

The evaluation of bcl-2 expression as a prognostic marker in early stage laryngeal cancer.

AIMS AND BACKGROUND: To evaluate the effect of bcl-2 expression on the local control and overall survival of patients with early stage laryngeal cancer treated with radiotherapy alone. METHODS AND STUDY DESIGN: We included 53 patients with stage Tis, T1, and T2 laryngeal cancer who were irradiated in our department. Paraffin blocks of all biopsy specimens were subjected to immunohistochemical analysis with a bcl-2 oncoprotein mouse clone 124 Scytek kit. RESULTS: The mean follow-up time was 61 months (range, 7-166). Local-regional recurrence was observed in 10 (19%) patients. Forty-three patients (81%) had negative bcl-2 staining, 5 patients (9%) had + staining, 3 patients (6%) ++ staining, and 2 patients (4%) +++ staining. No relationship was detected between bcl-2 expression and local control or overall survival. The emergence of a recurrence and a younger age (<50 years) were significantly related to poor overall survival (P = 0.000 and P = 0.021, respectively). Patients with hemoglobin levels in the middle of radiotherapy and at the end of radiotherapy higher than 13 g/dl had improved overall survival in multivariate analyses (P = 0.002 and P = 0.001, respectively). Regarding local control, the following were poor prognostic factors: smoking more than 20 cigarettes a day (P = 0.001) and being younger than 50 years of age (P = 0.001). CONCLUSIONS: No correlation was observed between bcl-2 expression and local control or overall survival. Whereas hemoglobin level, age and existence of a recurrence had a prognostic impact on overall survival, patient age and smoking status influenced local control rates.

Comparison of protracted infusion 5-fluorouracil and capecitabine in adjuvant chemoradiotherapy for rectal cancer.

BACKGROUND/AIMS: 5-Fluorouracil-based chemoradiotherapy is the most widely used treatment modality in the adjuvant treatment of rectal cancer. Capecitabine represents a valuable alternative to 5-Fluorouracil in this situation. METHODOLOGY: Patients with stage II and stage III rectal adenocarcinoma, who were included in this analysis, received adjuvant chemoradiotherapy consisting of external-beam radiotherapy (50.4-54Gy) either with 5-Fluorouracil at a median dose of 300 mg/m2/day by protracted venous infusion for 5 days a week, or capecitabine at a median dose of 1650 mg/m2/day for 5 days a week after surgery. The data concerning the toxicity and the efficacy of the treatments were compared in patients treated with 5-Fluorouracil- and capecitabine-based chemoradiotherapy. RESULTS: Forty-three patients received 5-Fluorouracil, and 24 patients received capecitabine during adjuvant radiotherapy. Although there were no differences between the groups in terms of toxicity rates, distant metastasis-free survival, disease-free survival, and overall survival rates; a trend for improved loco-regional recurrence-free survival rate was observed in the capecitabine arm (p = 0.063). CONCLUSIONS: Capecitabine is at least as effective as 5-Fluorouracil in the postoperative treatment of rectal adenocarcinoma. Considering the trend for improved loco-regional recurrence-free survival rate in the capecitabine arm, it seems that the drug exerts better synergy with radiotherapy in this situation.

Carcinoma originating from aberrant breast tissue. A case report and review of the literature.

Carcinoma arising from ectopic breast tissue, either supernumerary breast or aberrant breast tissue, is extremely rare. Carcinoma occurs more frequently in the ectopic breast tissue of the axilla than in extra-axillary ectopic breast tissue. Here we report a case of an invasive lobular carcinoma arising from extra-axillary ectopic breast tissue and presenting as a subcutaneous nodule.

Factors influencing axillary node metastasis in breast cancer.

AIMS AND BACKGROUND: The status of the axillary lymph nodes at the time of diagnosis has been accepted as one of the most important prognostic factors for the overall and disease-free survival of patients with breast cancer. The aim of our study was to determine which factors influence axillary node involvement in invasive breast cancer. METHODS: The data presented here were obtained from 344 patients who were treated for invasive breast cancer at the Department of Radiation Oncology, Uludag University Medical College, Bursa, Turkey. Possible prognostic factors were categorized as patient related and tumor related. The Mann-Whitney U test was used for univariate analysis and logistic regression was used for multivariate analysis. RESULTS: In univariate analysis, a familial cancer history (P = 0.0042), age < 40 years (P = 0.0276), higher T stage (P < 0.0000), nipple involvement (P = 0.0345), skin involvement (P = 0.0270), perineural invasion (P = 0.0231), and lymphatic vessel invasion (P < 0.0000) were correlated with increased axillary node involvement. A higher incidence of > or = 4 involved lymph nodes was associated with higher T stage (P = 0.0004), nipple involvement (P = 0.0292), presence of an extensive intraductal component (P = 0.0023), skin involvement (P = 0.0008), perineural invasion (P = 0.0523), and lymphatic vessel invasion (P < 0.0000) in univariate analysis. In multivariate analysis, age < 40 years (P = 0.0454), cancer history within the family (P = 0.0024), higher T stage (P = 0.0339), lymphatic vessel invasion (P = 0.0003), and perineural invasion (P = 0.0408) were found to be independent factors for axillary lymph node positivity. Age < 40 years (P = 0.0221), perineural invasion (P = 0.0408), and an extensive intraductal component (P = 0.0132) were associated with an increased incidence of > or = 4 involved nodes in the logistic regression analysis. In patients with breast cancer, the incidence of axillary lymph node involvement was independently influenced by age < 40 years, presence of cancer history within the family, higher T stage, lymphatic vessel invasion, and perineural invasion. CONCLUSIONS: In conclusion, absence of familial cancer history, presence of lymphatic vessel invasion, higher T stage, and age below 40 years independently increased the risk of axillary node involvement. Presence of perineural invasion and lymphatic vessel invasion, age below 40, and an extensive intraductal component of more than 25% independently affected the risk of having > or = 4 nodes involved. Patients characterized by these factors may be classified into a higher risk group for nodal involvement, but more data are needed to define factors that can help in the decision-making regarding the omission of axillary treatment.

Synchronous breast cancer in spouses.

Breast cancer in both spouses is extremely rare. There are 7 metachronous cases and 1 synchronous case in the English literature. No case has been reported in which 1 of the spouses had bilateral breast cancer. In this paper, we report a synchronous pair of cases where 1 of the spouses (wife) had bilateral breast cancer and the other (husband) had breast cancer.

Phase II study of induction chemotherapy with gemcitabine plus 5-fluorouracil followed by gemcitabine-based concurrent chemoradiotherapy for unresectable locally advanced pancreatic cancer.

AIMS AND BACKGROUND: To evaluate the efficacy and tolerability of a new treatment approach including induction chemotherapy (CT) and concurrent chemoradiotherapy (CRT) in unresectable, locally advanced pancreatic cancer (LAPC). PATIENTS AND METHODS: Twenty-four patients with LAPC were enrolled in the study. They first received induction CT consisting of 5-fluorouracil (5FU) (500 mg/m2) and gemcitabine (1000 mg/m2), which were given weekly for 3 weeks of every 4. Patients showing a response or disease stabilization after 2 cycles of induction CT received CRT consisting of external beam radiotherapy (50.4-54 Gy in fractions of 1.8 Gy/day) and gemcitabine (350 mg/m2, weekly for 6 weeks). Patients without disease progression received 2 additional cycles of CT consisting of 5FU plus gemcitabine with the same doses and schedule as given in the induction CT. RESULTS: After the end of the study, 2 (8%) and 5 (21%) patients showed complete and partial responses, respectively. Five patients (21%) had disease stabilization. The grade 3 and 4 toxicities associated with CT were neutropenia (21%) and thrombocytopenia (4%). The grade 3 and 4 toxicities occurring in patients who received CRT were neutropenia (24%), thrombocytopenia (24%), diarrhea (18%), and nausea (12%). The median progression-free survival for all patients was 6 months (95% CI, 3.6-8.4), and the median overall survival was 11 months (95% CI, 8.16-13.84). CONCLUSIONS: The CRT approach of this study is moderately active and has an acceptable toxicity profile. However, the incorporation of combination CT into CRT at the present schedule could not produce any additional benefit over CRT alone. Newer agents with more systemic activity are clearly warranted.