PURPOSE The previously published single institution randomized prospective trial failed to show superiority in the 5-year biochemical and/or clinical disease failure (BCDF) rate with moderate hypofractionated intensity-modulated radiation therapy (H-IMRT) versus conventionally fractionated IMRT (C-IMRT). We now present 10-year disease outcomes using updated risk groups and definitions of biochemical failure. METHODS Men with protocol-defined intermediate- and high-risk prostate adenocarcinoma were randomly assigned to receive C-IMRT (76 Gy in 38 fractions) or H-IMRT (70.2 Gy in 26 fractions). Men with high-risk disease were all prescribed 24 months of androgen deprivation therapy (ADT) and had lymph node irradiation. Men with intermediate risk were prescribed 4 months of ADT at the discretion of the treating physician. The primary endpoint was cumulative incidence of BCDF. We compared disease outcomes and overall mortality by treatment arm, with sensitivity analyses for National Comprehensive Cancer Network (NCCN) risk group adjustment. RESULTS Overall, 303 assessable men were randomly assigned to C-IMRT or H-IMRT. The median follow-up was 122.9 months. Per updated NCCN risk classification, there were 28 patients (9.2%) with low-risk, 189 (62.4%) with intermediate-risk, and 86 (28.4%) with high-risk prostate cancer. The arms were equally balanced for clinicopathologic factors, except that there were more black patients in the C-IMRT arm (17.8% v 7.3%; P = .02). There was no difference in ADT use ( P = .56). The 10-year cumulative incidence of BCDF was 25.9% in the C-IMRT arm and was 30.6% in the H-IMRT arm (hazard ratio, 1.31; 95% CI, 0.82 to 2.11). The two arms also had similar cumulative 10-year rates of biochemical failure, prostate cancer–specific mortality, and overall mortality; however, the 10-year cumulative incidence of distant metastases was higher in the H-IMRT arm (rate difference, 7.8%; 95% CI, 0.7% to 15.1%). CONCLUSION H-IMRT failed to demonstrate superiority compared with C-IMRT in long-term disease outcomes.
IMPORTANCE Multidisciplinary care (MDC) yields proven benefits for patients with cancer, although it may be underused in the complex management of head and neck squamous cell carcinoma (HNSCC).OBJECTIVE To characterize the patterns of MDC in the treatment of HNSCC among elderly patients in the US. DESIGN, SETTING, AND PARTICIPANTSThis nationwide, population-based, retrospective cohort study used Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data from January 1, 1991, to December 31, 2011, to identify patients 66 years or older diagnosed with head and neck cancer and determine the dates of diagnosis, oncology consultations, treatment initiation, and speech therapy evaluation in addition to MDC completion. Multidisciplinary care was defined in a stage-dependent manner: localized disease necessitated consultations with radiation and surgical oncologists, and advanced-stage disease also included a medical oncology consultation, all before definitive treatment. Data were analyzed between December 2016 and September 2020. MAIN OUTCOMES AND MEASURESRates of MDC across all subsites of head and neck cancer as measured by the presence of an evaluation for each oncologist on the MDC team and its effect on treatment initiation. RESULTSThis cohort study assessed 28 293 patients with HNSCC (mean [SD] age, 75.1 [6.6] years; 67% male; 87% White) from the SEER-Medicare linked database. The HNSCC subsites included larynx (40%), oral cavity (30%), oropharynx (21%), hypopharynx (7%), and nasopharynx (2%). Overall, the practice of MDC significantly increased over time, from 24% in 1991 to 52% in 2011 (P < .001). For patients with localized (stage 0-II) tumors, 60% received care in the multidisciplinary setting, whereas 28% of those with advanced-stage disease did. A total of 18 181 patients (64%) were treated with initial definitive nonsurgical therapy across all stages. Regardless of stage and subsite, few patients (2%) underwent evaluation by a speech-language pathologist before definitive therapy. Multidisciplinary care prolonged the time to initiation of definitive treatment by 11 days for localized disease and 10 days for advanced disease.CONCLUSIONS AND RELEVANCE This cohort study found that most elderly patients with localized HNSCC received MDC, whereas few patients with advanced-stage disease received such care, although a significant proportion received adjuvant therapy. Multidisciplinary care may prolong time to initiation of definitive treatment with an uncertain impact. Consultation with a speech-language pathologist before definitive therapy was rare.
Background: Compare adjuvant radiation dose trends and outcomes in head and neck squamous cell carcinoma (HNSCC). Methods: Nonmetastatic HNSCCs treated between 2004 and 2014 with primary site surgery, lymph node dissection, and adjuvant radiation were identified in the National Cancer Database. Standard dose radiation (SD-RT) was defined as an equivalent dose in 2 Gy (EQD2) ≥56.64 and ≤60 Gy and high-dose radiation (HD-RT) as an EQD2 >60 and <70 Gy. Results: HD-RT was given to 46% of the 15 836 HNSCC patients managed with adjuvant radiation. When adjusted for poor prognostic factors, HD-RT was associated with increased mortality (HR1.09; 95%CI 1.02-1.16). In nonoropharynx or human papillomavirus-negative oropharynx primary that had positive margins, ≥5 positive lymph nodes, and/or extranodal extension, HD-RT was still not associated with improved survival (HR 1.01, 95% CI 0.91-1.12). Conclusions: There was no survival benefit from postoperative dose escalation above EQD2 60 Gy even in a high-risk cohort.
The purpose of our study was to compare acute and late toxicities of high dose rate (HDR) brachytherapy and low dose rate (LDR) permanent iodine or palladium seeds as monotherapy in patients with low and favorable intermediate risk prostate cancer. Materials/Methods: We retrospectively examined patients with biopsy proven, low to favorable intermediate risk prostate cancer treated with interstitial brachytherapy monotherapy from 1998-2016 at a single institution. Patients selected were restricted to T stage T2c, Gleason score 7, and prostate specific antigen (PSA) less than 20 ng/ml. For each case of prostate brachytherapy, needles/seeds were implanted transperineally via trans-rectal ultrasound guidance. Dose for LDR was 145 Gy and HDR was 27 Gy in 2 fractions. The Common Toxicity Criteria scale, version 2.0 and 3.0 were used to score the acute (<12 months after brachytherapy) and late (! 12 months after brachytherapy) toxicities. Chi square analysis tested for associations between toxicity and treatment technique. Logistic regression was used in multivariable analyses (MVA). Results: A total of 572 patients were included, including 97 treated with HDR using 192 iridium ( 192 Ir), and 475 treated with LDR using 125 iodine ( 125 I) or 103 palladium ( 103 Pd). The median follow up time was 9.2months (range 3.1-145.3) for HDR patients and 53.1 months (range 0.2-198.6) for LDR patients. The two treatment groups were well-balanced with respect to age, T stage, ethnicity, and implanted prostate gland volume. A majority of patients had T1c disease and pretreatment PSA less than 10 ng/ml. 69% of HDR patients had Gleason score of 7 while 2.5% of LDR patients had Gleason score of 7. On univariate analysis, HDR brachytherapy was associated with lower rate of grade 2+ acute GU toxicity (14% vs 38%, p <0.0001) and grade 2+ late GU toxicity (10% vs 31%, p< 0.0001). Acute GI toxicity was low at 3% for both HDR and LDR; late GI toxicity were 6% and 7% (pZ 0.63) for HDR and LDR, respectively. In MVA, only LDR was independently associated with increased risk of grade 2+ acute GU toxicity (OR 2.4, 95% CI 1.1-5.3), but it was no longer associated with increased risk of grade 2+ late GU toxicity (OR 1.0, 95% CI 0.5-2.3). MVA demonstrated no difference between the two treatment methods with regard to acute or late GI toxicity. Conclusion: Acute and late GI toxicity was rare in patients treated with brachytherapy. The use of HDR brachytherapy as monotherapy was associated with a significantly lower risk of grade 2+ acute GU toxicity but similar grade 2+ late GU toxicity compared to LDR. Our results suggest HDR may be the preferred brachytherapy option in patients with clinically localized prostate cancer due to the better acute safety profile.
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