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1.
Ann Oncol ; 30(8): 1298-1303, 2019 08 01.
Article in English | MEDLINE | ID: mdl-31192355

ABSTRACT

BACKGROUND: This trial evaluated whether preoperative short-course radiotherapy and consolidation chemotherapy (CCT) were superior to chemoradiation in rectal cancers with clinical (c)T4 or fixed cT3. Previously, we reported early results showing no differences in the radical surgery rate (primary end point). In the short-course/CCT group, we observed lower acute toxicity of preoperative treatment and better overall survival (OS). We updated results to determine whether the benefit in OS was sustained and to evaluate late complications. PATIENTS AND METHODS: Patients with cT4 or fixed cT3 rectal cancer were randomized either to preoperative 5 × 5 Gy and three cycles of FOLFOX4 or to chemoradiation (50.4 Gy with bolus 5-Fu, leucovorin and oxaliplatin). RESULTS: Patients (N = 515) were eligible for analysis, 261 in the short-course/CCT group and 254 in the chemoradiation group. The median follow-up was 7.0 years. The difference in OS was insignificant [hazard ratio (HR) 0.90; 95% confidence interval (CI) 0.70-1.15; P = 0.38). However, the difference in early OS favouring short-course/CCT previously reported was observed again, being 9% at 3 years (95% CI 0.5% to 17%). This difference disappeared later; at 8 years OS was 49% in both groups. There was no difference in disease-free survival (HR 0.95; 95% CI 0.75-1.19; P = 0.65) at 8 years 43% versus 41% in the short-course/CCT group versus the chemoradiation group, respectively. The corresponding values for cumulative incidences of local failure and distant metastases did not differ and were HR = 1.08, 95% CI 0.70-1.23, P = 0.60, 35% versus 32% and HR = 1.10, 95% CI 0.68-1.23, P = 0.54, 36% versus 34%, respectively. The rate of late complications was similar (P = 0.66), grade 3+ being 11% versus 9% in the short-course/CCT group versus the chemoradiation group, respectively. CONCLUSION: The superiority of preoperative short-course/CCT over chemoradiation was not demonstrated. CLINICAL TRIAL NUMBER: The trial is registered as ClinicalTrials.gov number NCT00833131.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Dose Fractionation, Radiation , Neoadjuvant Therapy/methods , Neoplasm Recurrence, Local/epidemiology , Rectal Neoplasms/therapy , Adolescent , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Chemoradiotherapy/adverse effects , Chemoradiotherapy/methods , Consolidation Chemotherapy/adverse effects , Consolidation Chemotherapy/methods , Disease-Free Survival , Female , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Follow-Up Studies , Humans , Incidence , Leucovorin/administration & dosage , Leucovorin/adverse effects , Male , Middle Aged , Neoadjuvant Therapy/adverse effects , Neoplasm Recurrence, Local/prevention & control , Organoplatinum Compounds/administration & dosage , Organoplatinum Compounds/adverse effects , Poland/epidemiology , Proctectomy , Rectal Neoplasms/mortality , Rectal Neoplasms/pathology , Rectum/drug effects , Rectum/pathology , Rectum/radiation effects , Rectum/surgery , Time Factors , Young Adult
2.
Clin. transl. oncol. (Print) ; 18(5): 480-488, mayo 2016. tab, ilus
Article in English | IBECS | ID: ibc-151181

ABSTRACT

Purpose: To identify the main difficulties in postoperative clinical target volume (CTV) delineation in gastric cancer (GC). Methods: Before and after a training course, 20 radiation oncology residents were asked to delineate the CTV for the postoperative GC case on four computed tomography scans: dome of the diaphragm, anterior abdominal wall, duodenal stump and porta hepatis level, and to determine the lower CTV border. CTV volume was reconstructed from requested planar contours. Area of intersection (AI) for each requested scan and volume of intersection (VI), defined as the overlap of delineated area/volume with respective reference area (RA)/reference volume (RV) proposed by the senior radiation oncologist, were computed. The degree of agreement between the reference and participants’ contours was quantified using the Concordance Index (CI): AI/RA 9 100 % or VI/RV 9 100 %. The lower CTV border was analyzed separately. Pre- and post-training CIs were compared. A questionnaire investigated the difficulties with contouring. Results: Mean CI value was the lowest for the dome of the diaphragm (24 % pre-training, 35 % post-training) and for the duodenal stump (49 % pre-training, 61 % post-training). Mean CI for the CTV volume was 49 % pre-training and 59 % post-training, p = 0.39. Mean distance from the reference to the participants’ lower CTV borders was 2.73 cm pre-training and 2.0 cm post-training, p = 0.71. In a questionnaire, 75 % of respondents indicated the elective nodal area as the main difficulty. Conclusions: Delineation of the dome of the diaphragm and the duodenal stump, as yet not recognized as the source of variation, should be addressed in the international consensus guidelines and clarified (AU)


No disponible


Subject(s)
Humans , Male , Female , Stomach Neoplasms/radiotherapy , Radiotherapy/methods , Radiotherapy , Diaphragm/pathology , Diaphragm/radiation effects , Duodenum/pathology , Duodenum , Radiotherapy, Adjuvant/instrumentation , Radiotherapy, Adjuvant/methods , Radiotherapy, Adjuvant , Medical Oncology , Radiation Oncology , Tomography, Emission-Computed , Gastric Stump/physiopathology , Gastric Stump , Surveys and Questionnaires , Radiotherapy, Adjuvant/trends
3.
Clin Transl Oncol ; 18(5): 480-8, 2016 May.
Article in English | MEDLINE | ID: mdl-26311079

ABSTRACT

PURPOSE: To identify the main difficulties in postoperative clinical target volume (CTV) delineation in gastric cancer (GC). METHODS: Before and after a training course, 20 radiation oncology residents were asked to delineate the CTV for the postoperative GC case on four computed tomography scans: dome of the diaphragm, anterior abdominal wall, duodenal stump and porta hepatis level, and to determine the lower CTV border. CTV volume was reconstructed from requested planar contours. Area of intersection (AI) for each requested scan and volume of intersection (VI), defined as the overlap of delineated area/volume with respective reference area (RA)/reference volume (RV) proposed by the senior radiation oncologist, were computed. The degree of agreement between the reference and participants' contours was quantified using the Concordance Index (CI): AI/RA × 100% or VI/RV × 100%. The lower CTV border was analyzed separately. Pre- and post-training CIs were compared. A questionnaire investigated the difficulties with contouring. RESULTS: Mean CI value was the lowest for the dome of the diaphragm (24% pre-training, 35 % post-training) and for the duodenal stump (49% pre-training, 61% post-training). Mean CI for the CTV volume was 49% pre-training and 59% post-training, p = 0.39. Mean distance from the reference to the participants' lower CTV borders was 2.73 cm pre-training and 2.0 cm post-training, p = 0.71. In a questionnaire, 75% of respondents indicated the elective nodal area as the main difficulty. CONCLUSIONS: Delineation of the dome of the diaphragm and the duodenal stump, as yet not recognized as the source of variation, should be addressed in the international consensus guidelines and clarified.


Subject(s)
Adenocarcinoma/pathology , Observer Variation , Practice Guidelines as Topic/standards , Radiotherapy Planning, Computer-Assisted/methods , Stomach Neoplasms/pathology , Adenocarcinoma/radiotherapy , Adenocarcinoma/surgery , Gastrectomy , Humans , Male , Middle Aged , Neoplasm Staging , Postoperative Care , Prognosis , Radiotherapy Dosage , Stomach Neoplasms/radiotherapy , Stomach Neoplasms/surgery , Tumor Burden
4.
Ann Oncol ; 26(6): 1134-1142, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25722382

ABSTRACT

BACKGROUND: Tecemotide is a MUC1-antigen-specific cancer immunotherapy. The phase III START study did not meet its primary end point but reported notable survival benefit with tecemotide versus placebo in an exploratory analysis of the predefined patient subgroup treated with concurrent chemoradiotherapy. Here, we attempted to gain further insight into the effects of tecemotide in START. PATIENTS AND METHODS: START recruited patients who did not progress following frontline chemoradiotherapy for unresectable stage III non-small-cell lung cancer. We present updated overall survival (OS) data and exploratory analyses of OS for baseline biomarkers: soluble MUC1 (sMUC1), antinuclear antibodies (ANA), neutrophil/lymphocyte ratio (NLR), lymphocyte count, and HLA type. RESULTS: Updated OS data are consistent with the primary analysis: median 25.8 months (tecemotide) versus 22.4 months (placebo) (HR 0.89, 95% CI 0.77-1.03, P = 0.111), with ∼20 months additional median follow-up time compared with the primary analysis. Exploratory analysis of the predefined subgroup treated with concurrent chemoradiotherapy revealed clinically relevant prolonged OS with tecemotide versus placebo (29.4 versus 20.8 months; HR 0.81, 95% CI 0.68-0.98, P = 0.026). No improvement was seen with sequential chemoradiotherapy. High sMUC1 and ANA correlated with a possible survival benefit with tecemotide (interaction P = 0.0085 and 0.0022) and might have future value as biomarkers. Interactions between lymphocyte count, NLR, or prespecified HLA alleles and treatment effect were not observed. CONCLUSION: Updated OS data support potential treatment benefit with tecemotide in patients treated with concurrent chemoradiotherapy. Exploratory biomarker analyses suggest that elevated sMUC1 or ANA levels correlate with tecemotide benefit. CLINICALTRIALSGOV NUMBER: NCT00409188.


Subject(s)
Biomarkers, Tumor/blood , Cancer Vaccines/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Lung Neoplasms/drug therapy , Membrane Glycoproteins/therapeutic use , Mucin-1/blood , Adult , Aged , Aged, 80 and over , Antibodies, Antinuclear/blood , Cancer Vaccines/adverse effects , Carcinoma, Non-Small-Cell Lung/blood , Carcinoma, Non-Small-Cell Lung/immunology , Carcinoma, Non-Small-Cell Lung/mortality , Carcinoma, Non-Small-Cell Lung/pathology , Chemoradiotherapy, Adjuvant , Female , Humans , Kaplan-Meier Estimate , Lung Neoplasms/blood , Lung Neoplasms/immunology , Lung Neoplasms/mortality , Lung Neoplasms/pathology , Lymphocyte Count , Male , Membrane Glycoproteins/adverse effects , Middle Aged , Mucin-1/immunology , Neutrophils , Predictive Value of Tests , Proportional Hazards Models , Risk Factors , Time Factors , Treatment Outcome , Young Adult
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