Apparent diffusion coefficient values predict response to brachytherapy in bulky cervical cancer.

BACKGROUND: Diffusion-weighted magnetic resonance imaging (DWI) provides a measurement of tumor cellularity. We evaluated the potential of apparent diffusion coefficient (ADC) values obtained from post-external beam radiation therapy (EBRT) DWI and prior to brachytherapy (BT) to predict for complete metabolic response (CMR) in bulky cervical cancer. METHODS: Clinical and DWI (b value = 500 s/mm2) data were obtained from patients undergoing interstitial BT with high-risk clinical target volumes (HR-CTVs) > 30 cc. Volumes were contoured on co-registered T2 weighted images and 90th percentile ADC values were calculated. Patients were stratified by CMR (defined by PET-CT at three months post-BT). Relation of CMR with 90th percentile ADC values and other clinical factors (International Federation of Gynecology and Obstetrics (FIGO) stage, histology, tumor and HR-CTV size, pre-treatment hemoglobin, and age) was assessed both in univariate and multivariate logistic regression analyses. Youden's J statistic was used to identify a threshold value. RESULTS: Among 45 patients, twenty-eight (62%) achieved a CMR. On univariate analysis for CMR, only 90th percentile ADC value was significant (p = 0.029) while other imaging and clinical factors were not. Borderline significant factors were HR-CTV size (p = 0.054) and number of chemotherapy cycles (p = 0.078). On multivariate analysis 90th percentile ADC (p < 0.0001) and HR-CTV size (p < 0.003) were highly significant. Patients with 90th percentile ADC values above 2.10 × 10- 3 mm2/s were 5.33 (95% CI, 1.35-24.4) times more likely to achieve CMR. CONCLUSIONS: Clinical DWI may serve to risk-stratify patients undergoing interstitial BT for bulky cervical cancer.

Testicular Dysfunction in Male Childhood Cancer Survivors Treated With Radiation Therapy: A PENTEC Comprehensive Review.

PURPOSE: The male reproductive task force of the Pediatric Normal Tissue Effects in the Clinic (PENTEC) initiative performed a comprehensive review that included a meta-analysis of publications reporting radiation dose-volume effects for risk of impaired fertility and hormonal function after radiation therapy for pediatric malignancies. METHODS AND MATERIALS: The PENTEC task force conducted a comprehensive literature search to identify published data evaluating the effect of testicular radiation dose on reproductive complications in male childhood cancer survivors. Thirty-one studies were analyzed, of which 4 had testicular dose data to generate descriptive scatter plots. Two cohorts were identified. Cohort 1 consisted of pediatric and young adult patients with cancer who received scatter radiation therapy to the testes. Cohort 2 consisted of pediatric and young adult patients with cancer who received direct testicular radiation therapy as part of their cancer therapy. Descriptive scatter plots were used to delineate the relationship between the effect of mean testicular dose on sperm count reduction, testosterone, follicle stimulating hormone (FSH), and luteinizing hormone (LH) levels. RESULTS: Descriptive scatter plots demonstrated a 44% to 80% risk of oligospermia when the mean testicular dose was <1 Gy, but this was recovered by >12 months in 75% to 100% of patients. At doses >1 Gy, the rate of oligospermia increased to >90% at 12 months. Testosterone levels were generally not affected when the mean testicular dose was <0.2 Gy but were abnormal in up to 25% of patients receiving between 0.2 and 12 Gy. Doses between 12 and 19 Gy may be associated with abnormal testosterone in 40% of patients, whereas doses >20 Gy to the testes were associated with a steep increase in abnormal testosterone in at least 68% of patients. FSH levels were unaffected by a mean testicular dose <0.2 Gy, whereas at doses >0.5 Gy, the risk was between 40% and 100%. LH levels were affected at doses >0.5 Gy in 33% to 75% of patients between 10 and 24 months after radiation. Although dose modeling could not be performed in cohort 2, the risk of reproductive toxicities was escalated with doses >10 Gy. CONCLUSIONS: This PENTEC comprehensive review demonstrates important relationships between scatter or direct radiation dose on male reproductive endpoints including semen analysis and levels of FSH, LH, and testosterone.

A pooled long-term follow-up after radiotherapy for prostate cancer with and without a rectal hydrogel spacer: impact of hydrogel on decline in sexual quality of life.

Purpose: The purpose of this study was to analyze the impact of prostate rectal spacers on sexual quality of life (QOL) following external beam radiation therapy (RT). Methods and materials: Patient- reported QOL was evaluated using the Expanded Prostate Cancer Index Composite (EPIC). Patients were pooled from two sources: a randomized controlled trial and a non-randomized cohort of patients from a single institution. Both cohorts used the same spacing product and QOL instrument. Analysis was limited to those with good baseline pre-treatment sexual QOL (EPIC >/= 60). Differences in QOL summary score and individual items were assessed compared with baseline and between treatment arms. Results: A total of 128 men had good baseline sexual function and were evaluated (64% with spacer and 36% without) with QOL data available for median 33 months (range: 2.5-69.4 months). Men without spacer were more likely to have declines in sexual function (p < 0.0001), bother (p = 0.0002), and sexual summary score (p < 0.0001). A minimally important difference of 10 points (1xMID) and 20 point (2xMID) was more likely without rectal spacer [10 points: odds ratio 3.53, (95% confidence interval 1.11-11.2), p = 0.032; 20 points: odds ratio 3.29, (95% confidence interval 1.16-9.33), p = 0.025]. Seven of 13 QOL items were statistically superior with hydrogel (six of nine functional and one of four bother), while no items were statistically superior for control. At baseline, more men treated with hydrogel had erections sufficient for intercourse; however, when analyzed only by the men with best baseline erectile potential and excluding those with worse function, the benefit of rectal spacing was maintained with a higher likelihood of preservation of erections sufficient for intercourse in those treated with hydrogel. Conclusion: In this pooled analysis of QOL after prostate RT, the utilization of a hydrogel spacer was associated with better sexual QOL, less men with measurable declines in sexual QOL, and higher rates of adequate erectile function.

Validation of the Combination Gleason Score as an Independent Favorable Prognostic Factor in Prostate Cancer Treated With Dose-Escalated Radiation Therapy.

PURPOSE: Prognostic factors for prostate cancer include tumor, node, metastases stage, pretreatment prostate-specific antigen, and pathology (via Gleason score [GS] or grade group). Of these, GS yields the largest effect on prostate cancer specific mortality. It was previously determined that those with cores with a mix of higher and lower GS at biopsy (which was termed a "ComboGS") had decreased risk for prostate cancer specific mortality after either surgical or radiation treatment. We validate the effect of ComboGS in an independent cohort of patients with prostate cancer treated with definitive dose-escalated radiation therapy (DE-RT) at 2 institutions. METHODS AND MATERIALS: DE-RT was administered to 2539 men, of which 687 men had a ComboGS. To further ascertain the ComboGS effect we employed the modified Cancer of the Prostate Risk Assessment (mCAPRA) score. Rates of biochemical event-free survival and distant metastasis-free survival were compared across CAPRA scores, with and without modification, and the prognostic value of the CAPRA scores was compared using Harrel's concordance index. RESULTS: On univariate analysis in Gleason 7 to 10 patients the presence of ComboGS improved 10-year biochemical event-free survival from 76.6% to 82.4% (hazard ratio [HR], 0.75; confidence interval [CI], 0.59-0.96; P = .021), 10-year distant metastasis-free survival from 89.3% to 93.2% (HR, 0.57; CI, 0.39-0.85; P = .005), 10-year prostate cancer specific survival from 93.9% to 97.4% (HR, 0.39; CI, 0.21-0.7; P = .001), and 10-year overall survival from 65.7% to 75.6% (HR, 0.69; CI, 0.57-0.83; P < .001). Multivariable analysis also supported that ComboGS is protective for biochemical failure (HR, 0.64; CI, 0.50-0.83; P < .001), distant metastasis (HR, 0.42; CI, 0.28-0.63; P < .001), death from prostate cancer (HR, 0.32; CI, 0.17-0.58; P < .001), and overall mortality (HR, 0.65; CI, 0.54-0.79; P < .001). Additionally, adjusting the mCAPRA score for ComboGS decreased the risk of biochemical failure by nearly 30% (HR, 0.70; 95% CI, 0.55-0.88; P = .003) and by 50% (HR, 0.54; 95% CI, 0.37-0.80; P = .002) for distant metastasis. CONCLUSIONS: ComboGS is a useful and readily available independent prognostic factor for all clinical endpoints evaluated. Moreover, the ComboGS can be used in conjunction with the extensively validated CAPRA scoring to better risk stratify patients being treated with definitive DE-RT for GS 7 to 10 disease.

Predictors of follow-up non-compliance after definitive radiotherapy for locally advanced cervical cancer at a community cancer center.

Introduction: Non-compliance to post-treatment cancer surveillance can lead to late detection of recurrence. This study aims to identify patients at high risk for loss of follow-up after radiotherapy for locally advanced cervical cancer. Methods: Consecutive patients with locally advanced cervical cancer treated with definitive chemoradiotherapy (2013-2020) at a community cancer center were retrospectively reviewed. The main outcome was overall follow-up compliance rate over time. Additionally, specialist-specific follow-up times, reasons for discontinuation and predictors of loss of follow-up events were evaluated. Results: The median age of the 154 patients included was 46.5 years (range: 26-84). The 6-month, 1-, 3-, and 5-year overall loss of follow-up rates were: 5.3%, 15.3%, 33.6%, and 48.2%, respectively. After a median overall follow-up time of 21.0 months, the median specialist-specific surveillance times were 17 months and 6 months with gynecologic and radiation oncologists, respectively (p < 0.01). Overall, the most common reasons for loss of follow-up were financial (21.7%) and relocation to another city (28.3%). By specialty, the most common reasons were relocation of care (56.5%, gynecologic oncologist) and disease progression (31.3%, radiation oncologist). In the multivariable analysis, older age (continuous, OR: 0.96; p < 0.01) and Hispanic ethnicity (OR: 0.39; p < 0.01) were protective against loss of follow-up, while increased number of gestations (continuous, OR: 1.23, p = 0.01) and living farther from the cancer center (continuous, OR: 1.002; p = 0.03) increased the chance of loss of follow-up. Conclusion: Younger, non-Hispanic, multiparous women that live far from the community cancer center have an increased chance of follow-up discontinuity, which are attributed to financial reasons in more than 20% of the cases.

Patient reported outcomes for quality of life (QOL) by Expanded Prostate Cancer Index (EPIC) on average 15 years post treatment.

Objective/purpose: Previously patient reported quality of life (QOL) was reported in men with prostate cancer a mean 2 and 6 years post treatment with open radical prostatectomy (RP), 3D conformal radiation therapy (3D CRT), or 125I low dose rate (LDR) brachytherapy (BT). Herein we update the results 15 years post-treatment QOL. Materials/methods: The Expanded Prostate Cancer Index (EPIC) domains were scored with differences evaluated at a median 15.8 years follow up based upon mean EPIC summary domains by ANOVA with pairwise post-hoc comparisons adjusted for age. Patient differences of current survey from first cross-section are reported as median change in summary score for each treatment group at median of 2.2 and 6.0, and 15.8 years. Results: Among men still alive response rate was 52% in BT, 60% in 3D CRT, and 62% in RP resulting in 30, 41, and 330 QOL questionnaires to evaluate for each corresponding modality at median follow up of 15.8 years. Men were a mean 75.3, 83.6, and 79.3 years of age after RP, 3DCRT, and BT, respectively.At a median of 15.8 years, there were largely persistent differences in EPIC domains without substantial evolution in QoL from middle time points. Persistent worsening in urinary irritative and bowel domain with 3DRT or BT compared to RP. Trend towards worse urinary incontinence with RP were noted without statistical differences within radiotherapy options. Conclusion: As the EPIC patient reported outcomes with the longest follow-up, these data uniquely reveal temporal trends from 2 to 15 years post treatment. However, the treatment modalities of open RP, 3D CRT without image guidance or intensity modulation, and BT without peripheral loading or MRI guidance may not reflect modern techniques.

Two Specialists, Two Recommendations: Discordance Between Urologists' & Radiation Oncologists' Prostate Cancer Treatment Recommendations.

OBJECTIVE: To examine the treatment recommendation patterns among urologists and radiation oncologists, the level of concordance or discordance between physician recommendations, and the association between physician recommendations and the treatment that patients received. METHOD: The study was a secondary analysis of data from a randomized clinical trial conducted November 2010 to April 2014 (NCT02053389). Eligible participants were patients from the trial who saw both specialists. The primary outcome was physician recommendations that were scored using an adapted version of the validated PhyReCS coding system. Secondary outcomes included concordance between physician recommendations and the treatment patients received. RESULTS: Participants were 108 patients (Mean age 61.9 years; range 43-82; 87% non-Hispanic White). Urologists were more likely to recommend surgery (79% of recommendations) and radiation oncologists were more likely to recommend radiation (68% of recommendations). Recommendations from the urologists and radiation oncologists were concordant for only 33 patients (30.6%). Most patients received a treatment that both physicians recommended (59%); however, 35% received a treatment that only one of their physicians recommended. When discordant, urologists more often recommended surgery and radiation oncologists recommended radiation and surgery as equally appropriate options. CONCLUSION: Urologists and radiation oncologists are more likely to differ than agree in their treatment recommendations for the same patients with clinically localized prostate cancer and more likely to favor treatment aligned with their specialty. Additional studies are needed to better understand how patients make decisions after meeting with two different specialists to inform the development of best practices within oncology clinics.

Co-Inhibition of Androgen Receptor and PARP as a Novel Treatment Paradigm in Prostate Cancer-Where Are We Now?

Metastatic prostate cancer remains lethal with a 5-year survival rate of about 30%, indicating the need for better treatment options. Novel antiandrogens (NAA)-enzalutamide and abiraterone-have been the mainstay of treatment for advanced disease since 2011. In patients who progress on the first NAA, responses to the second NAA are infrequent (25-30%) and short-lasting (median PFS ~3 months). With the growing adoption of NAA therapy in pre-metastatic castration-resistant settings, finding better treatment options for first-line mCRPC has become an urgent clinical need. The regulatory approval of two PARP inhibitors in 2020-rucaparib and olaparib-has provided the first targeted therapy option for patients harboring defects in selected DNA damage response and repair (DDR) pathway genes. However, a growing body of preclinical and clinical data shows that co-inhibition of AR and PARP induces synthetic lethality and could be a promising therapy for patients without any DDR alterations. In this review article, we will investigate the limitations of NAA monotherapy, the mechanistic rationale for synthetic lethality induced by co-inhibition of AR and PARP, the clinical data that have led to the global development of a number of these AR and PARP combination therapies, and how this may impact patient care in the next 2-10 years.

Oral D-methionine protects against cisplatin-induced hearing loss in humans: phase 2 randomized clinical trial in India.

Objective: This exploratory Phase 2 clinical trial is the first determining safety and efficacy of oral D-methionine (D-met) in reducing cisplatin-induced ototoxicity.Design: Randomised parallel double-blind placebo-controlled exploratory Phase 2 study.Study samples: Fifty adult cancer patients received oral D-met or placebo before each cisplatin dose. Physical examination, blood collection and audiometry occurred at baseline and subsequent visits plus post-treatment audiometry. After attrition, final analysis included 27 patients.Results: Significant treatment group by ear and time (baseline vs. post-treatment) interactions occurred at 10 kHz and 11.2 kHz. Placebo and D-met groups differed in threshold shift for left ear at 11.2 kHz (mean difference = 22.97 dB [9.59, 36.35]). Averaging across ears, placebo group showed significant threshold shifts from baseline to post-treatment at 10 kHz (mean shift= -13.65 dB [-21.32,-5.98]), 11.2 kHz (-16.15 dB [-25.19,-7.12]), and 12.5 kHz (-11.46 dB [-19.18,-3.74]) but not 8 kHz (-8.65 dB [-17.86, 0.55]). The D-met group showed no significant threshold shifts (8 kHz: -1.25 dB [-7.75, 5.25]; 10 kHz:-3.93 dB [-8.89, 1.03]; 11.2 kHz:-4.82 dB [-11.21, 1.57]; 12.5 kHz:-3.68 dB [-11.57, 4.21]). Side effects did not significantly differ between groups.Conclusion: Oral D-met reduces cisplatin-induced ototoxicity in humans.

Preparing Patients with Early Stage Prostate Cancer to Participate in Clinical Appointments Using a Shared Decision Making Training Video.

BACKGROUND: Rates of shared decision making (SDM) are relatively low in early stage prostate cancer decisions, as patients' values are not well integrated into a preference-sensitive treatment decision. The study objectives were to develop a SDM training video, measure usability and satisfaction, and determine the effect of the intervention on preparing patients to participate in clinical appointments. METHODS: A randomized controlled trial was conducted to compare a plain-language decision aid (DA) to the DA plus a patient SDM training video. Patients with early stage prostate cancer completed survey measures at baseline and after reviewing the intervention materials. Survey items assessed patients' knowledge, beliefs related to SDM, and perceived readiness/intention to participate in their upcoming clinical appointment. RESULTS: Of those randomized to the DA + SDM video group, most participants (91%) watched the video and 93% would recommend the video to others. Participants in the DA + SDM video group, compared to the DA-only group, reported an increased desire to participate in the decision (mean = 3.65 v. 3.39, P < 0.001), less decision urgency (mean = 2.82 v. 3.39, P < 0.001), and improved self-efficacy for communicating with physicians (mean = 4.69 v. 4.50, P = 0.05). These participants also reported increased intentions to seek a referral from a radiation oncologist (73% v. 51%, P = 0.004), to take notes (mean = 3.23 v. 2.86, P = 0.004), and to record their upcoming appointments (mean = 1.79 v. 1.43, P = 0.008). CONCLUSIONS: A novel SDM training video was accepted by patients and changed several measures associated with SDM. This may be a scalable, cost-effective way to prepare patients with early stage prostate cancer to participate in their clinical appointments.[Box: see text].

Ethical Allocation of Proton Therapy and the Insurance Review Process.

PURPOSE: The purpose of this study was to delineate a scoring system to maximize the ethical allocation of proton beam therapy (PBT) and determine what factors are associated with receipt of PBT, including the role of specific insurance providers. METHODS AND MATERIALS: Our scoring system was developed in collaboration with a multidisciplinary panel of experts. Patients submitted for PBT consideration were assigned a score by committee at a weekly peer-reviewed session at a time when our center was operating at capacity. Univariate analysis and multivariable analysis of initial and final insurance response were performed. RESULTS: One hundred ninety-seven patients were prospectively reviewed. Ninety-three percent of patients with Medicaid coverage, 88% of patients with Medicare, and 78% of patients with private insurance were ultimately approved for PBT. Median time to final insurance response was 12 days (interquartile range, 9-18 days) for patients who were ultimately denied PBT coverage. Having primary provider C (odds ratio [OR], 14; 95% confidence interval [CI], 1.20-1.96; P = .033) or third party providers A (OR, 4.22; 95% CI, 1.71-10.9; P = .002) or B (OR, 5.28; 95% CI, 1.56-17.2; P = .006) was significantly associated with final insurance denial for PBT on univariate analysis. Total score (OR, 0.79; 95% CI, 0.67-0.90; P = .002) and having coverage through third party provider A (OR, 24.2; 95% CI, 9.51-68.9; P < .001) were associated with final insurance response on multivariable analysis. CONCLUSIONS: Our scoring system was significantly associated with receipt of proton beam therapy. Certain insurance providers are less likely to approve PBT for patients, all else being equal. Such a scoring system could be implemented effectively at other PBT facilities, and additional work is needed in ensuring patients with the most to gain from PBT will be approved by their insurance providers.

Long-term follow-up after radiotherapy for prostate cancer with and without rectal hydrogel spacer: a pooled prospective evaluation of bowel-associated quality of life.

OBJECTIVE: To evaluate the long-term bowel-associated quality of life (QOL) in men after radiotherapy (RT) for prostate cancer with and without the use of rectal hydrogel spacer. PATIENTS AND METHODS: The patients' QOL was examined using the Expanded Prostate Cancer Index Composite (EPIC) and mean changes from baseline in EPIC domains were evaluated. A total of 215 patients from a randomised multi-institutional trial of RT, with or without hydrogel spacer, with a QOL endpoint were pooled with 165 non-randomised patients from a single institution with prospective QOL collection in patients with or without hydrogel spacer. The proportions of men with minimally important differences (MIDs) relative to pre-treatment baseline in the bowel domain were tested using repeated measure logistic models with a pre-specified threshold for clinically significant declines (≥5 equivalent to MIDx1 and ≥10 equivalent to MIDx2). RESULTS: A total of 380 men were evaluated (64% with spacer and 36% without) with QOL data being available for 199 men with >24 months of follow-up [median (range) 39.5 (31-71.4) months]. Treatment with spacer was associated with less decline in average long-term bowel QOL (89.4 for control and 94.7 for spacer) with differences at >24 months meeting the threshold of a MID difference between cohorts (bowel score difference from baseline: control = -5.1, spacer = 0.3, difference = -5.4; P < 0.001). When evaluated over time men without spacer were more likely to have MIDx1 (5 points) declines in bowel QOL (P = 0.01). At long-term follow-up MIDx1 was 36% without spacer vs 14% with spacer (P <0.001; odds ratio [OR] 3.5, 95% CI 1.7-6.9) while MIDx2 was seen in 19% vs 6% (P = 0.008; OR 3.6, 95% CI 1.4-9.1). The use of spacer was associated with less urgency with bowel movements (P = 0.002) and fewer loose stools (P = 0.009), as well as less bother with urgency (P = 0.007) and frequency of bowel movements (P = 0.009). CONCLUSIONS: In this pooled analysis of QOL after prostate RT with up to 5 years of follow-up, use of a rectal spacer was associated with preservation of bowel QOL. This QOL benefit was preserved with long-term follow-up.

Who Benefits From a Prostate Rectal Spacer? Secondary Analysis of a Phase III Trial.

PURPOSE: Previously a phase III trial of a hydrogel rectal spacer during prostate radiation therapy found decreased toxicity and a clinically significant improvement in bowel quality of life (QOL) at 3 years by the Expanded Prostate Cancer Index. We performed a secondary analysis to identify men less likely to benefit. METHODS AND MATERIALS: Clinical and dosimetric data for the 222 patients enrolled on the SpaceOAR phase III trial were analyzed. The volume of rectum treated to 70 Gy (V70) and the quantitative analysis of normal tissue effects in the clinic (QUANTEC) rectal dose goals were used as surrogates for clinical benefit and plan quality. Mean bowel QOL was assessed at 15 and 36 months posttreatment and the likelihood of 1× (5 points) or 2× (10 points) minimally important difference changes were assessed. RESULTS: Rectal V70 was correlated with physician scored toxicity (P = .033) and was used as a surrogate for plan quality. There was no correlation between prostate volume and rectal V70 (r = 0.077). Rectal V70 pre- and post-hydrogel was 13% and 3% for the smallest prostates (<40 mL) and 12% and 2% for the largest (>80 mL). The relative reduction in rectal V70 of 78% did not vary by prespacer V70, but the absolute reduction was greater for a higher V70. All spacer plans met the 5 QUANTEC rectal dose constraints, although 92% of control plans met all constraints. At 3 years, those not meeting all QUANTEC goals had a 15.0-point (standard deviation 15.1) decline, control patients meeting QUANTEC goals had a 4.0-point (9.5) decline, and spacer had >0.5 (7.6; P < .01). Previous surgery was not correlated with QOL (P = .8). Across prognostic groups, including age, body mass index, previous surgery, target volume, or quality of radiation plans, there was no statistically significant heterogeneity in the relative benefit of spacer in decreasing the risk of 1× or 2× the minimally important difference declines. CONCLUSIONS: There was little heterogeneity in the likelihood of spacer reducing the risk of declines in bowel QOL across clinical and dosimetric variables. Even for the >95% of plans meeting QUANTEC rectal criteria, hydrogel spacer provided potentially meaningful benefits.

VA-Radiation Oncology Quality Surveillance Program.

PURPOSE: We sought to develop a quality surveillance program for approximately 15,000 US veterans treated at the 40 radiation oncology facilities at the Veterans Affairs (VA) hospitals each year. METHODS AND MATERIALS: State-of-the-art technologies were used with the goal to improve clinical outcomes while providing the best possible care to veterans. To measure quality of care and service rendered to veterans, the Veterans Health Administration established the VA Radiation Oncology Quality Surveillance program. The program carries forward the American College of Radiology Quality Research in Radiation Oncology project methodology of assessing the wide variation in practice pattern and quality of care in radiation therapy by developing clinical quality measures (QM) used as quality indices. These QM data provide feedback to physicians by identifying areas for improvement in the process of care and identifying the adoption of evidence-based recommendations for radiation therapy. RESULTS: Disease-site expert panels organized by the American Society for Radiation Oncology (ASTRO) defined quality measures and established scoring criteria for prostate cancer (intermediate and high risk), non-small cell lung cancer (IIIA/B stage), and small cell lung cancer (limited stage) case presentations. Data elements for 1567 patients from the 40 VA radiation oncology practices were abstracted from the electronic medical records and treatment management and planning systems. Overall, the 1567 assessed cases passed 82.4% of all QM. Pass rates for QM for the 773 lung and 794 prostate cases were 78.0% and 87.2%, respectively. Marked variations, however, were noted in the pass rates for QM when tumor site, clinical pathway, or performing centers were separately examined. CONCLUSIONS: The peer-review protected VA-Radiation Oncology Surveillance program based on clinical quality measures allows providers to compare their clinical practice to peers and to make meaningful adjustments in their personal patterns of care unobtrusively.

Gleason pattern 5 is associated with an increased risk for metastasis following androgen deprivation therapy and radiation: An analysis of RTOG 9202 and 9902.

BACKGROUND/PURPOSE: Stratification of Gleason score (GS) into three categories (2-6, 7, and 8-10) may not fully utilize its prognostic discrimination, with Gleason pattern 5 (GP5) previously identified as an independent adverse factor. MATERIALS/METHODS: Patients treated on RTOG 9202 (n = 1292) or RTOG 9902 (n = 378) were pooled and assessed for association of GS and GP5 on biochemical failure (BF), local failure (LF), distant metastasis (DM), and overall survival (OS). Fine and Gray's regression and cumulative incidence methods were used for univariate and multivariate analyses. RESULTS: With median follow-up of 9.4 years, patients with GS 8-10 with GP5 had worse outcome than GS 4 + 4 for DM on both RTOG9202 (p = 0.038) and RTOG9902 (p < 0.001) with a trend toward worse OS (p = 0.059 and p = 0.089, respectively), but without differences in BF or LF. At 10-years DM was higher by 11% (RTOG 9202) and 18% (RTOG 9902) with GP5 compared to GS 4 + 4. On multivariate analysis restricted to long-term androgen deprivation therapy the presence of GP5 substantially increased distant metastasis (HR = 0.43, 95%CI: 0.24-0.76, p = 0.0039) with a trend toward worse OS (HR:0.74, 95% CI:0.54-1.0, p = 0.052) without association with LF (HR:0.55, 95%CI:0.28-1.09, p = 0.085) or BF (HR:1.15, 95%CI:0.84-1.59, p = 0.39). We did not observed substantial differences between Gleason 3 + 5, 5 + 3, or Gleason 9-10. CONCLUSIONS: These results validate GP5 as an independent prognostic factor which is strongest for DM. As a result GP5 should be considered when stratifying patients with GS 8 and may be a patient population in which to evaluate newly approved systemic therapies or additional local treatments.