Bending the cost curve: a unique collaboration between radiation oncologists and Blue Cross Blue Shield of Massachusetts to optimize the use of advanced technology.

PURPOSE: Intensity-modulated radiation therapy (IMRT) limits the dose of radiation to critical normal tissue structures and can be applied to the management of most cancers treated with radiation therapy. Because of increased treatment planning time and quality assurance, IMRT is costly. Blue Cross Blue Shield of Massachusetts (BCBSMA) and the Massachusetts Radiation Oncology Physicians Advisory Council (PAC) developed a strategy to develop standards for the appropriate use of IMRT. METHODS: Normal tissue volume guidelines were established in multiple oncology disease areas and body site regions. Guidelines were activated in September 2011, and the use of IMRT per case was tracked quarterly by BCBSMA staff. RESULTS: During the first year of activation of the volume-based guidelines, use of IMRT decreased by 17% in Massachusetts, in contrast to a 20% increase during the previous year. CONCLUSIONS: The normal tissue-based guidelines have decreased the use of IMRT in Massachusetts; increased the use of 3D treatment; continued communication between treating radiation oncologists and an insurance organization responsible for cost and quality in medicine; increased cost savings; enabled an efficient appeal process; and provided optimal, cost-effective patient care. This may prove to be an effective model for other disciplines and other developing and maturing radiation technologies.

Postsurgical treatment of early-stage breast cancer with electronic brachytherapy: outcomes and health-related quality of life at 1 year.

OBJECTIVES: This multicenter registry followed up patients with early-stage breast cancer treated with breast-conserving surgery and electronic brachytherapy (EBT). This report provides 1- and 2-year updates to the initial publication. METHODS: Patients were of age 50 years or more with invasive carcinoma or ductal carcinoma in situ, tumor size ≤3 cm, and negative surgical margins. After lumpectomy, patients received EBT in 10 fractions over 5 days (34 Gy total). RESULTS: Of the 69 patients enrolled, 62 were evaluated at 1 year and 20 patients at 2 years after treatment. At 1 year, 28 (45.2%) patients reported adverse events that were possibly, probably, or definitely related to treatment. Most (90%) were grade 1: manageable and typical of radiation therapy. Four events were grade 2: induration/firmness (2), field contracture (1), and seroma (1). One event was grade 3: a draining fistula at the lumpectomy site due to residual effects of a breast infection at 1 month. No recurrences have been reported. Cosmetic ratings were excellent or good in 93.4% of patients at 1 year. Most patients (69%) were energetic most or all of the time. Most patients (69% to 98%) were not affected by individual symptoms of breast disease at 1 year. Generally patients who had an adverse event did not report the corresponding symptom on the quality-of-life questionnaire. CONCLUSIONS: This registry followed up patients with early-stage breast cancer at 1 and 2 years after breast-conserving surgery and EBT. No recurrences have been reported, and adverse effects were acceptable.

Hyperthermia combined with radiation for the treatment of locally advanced prostate cancer: long-term results from Dana-Farber Cancer Institute study 94-153.

BACKGROUND: The authors present long-term results from a phase 2 study that assessed the efficacy of transrectal ultrasound hyperthermia plus radiation with or without androgen suppression for the treatment of locally advanced prostate cancer. METHODS: Patients with clinical T2b-T3bN0M0 disease (according to 1992 American Joint Committee on Cancer [AJCC] criteria) received radiation plus 2 transrectal ultrasound hyperthermia treatments. After the first 4 patients, 6 months of androgen suppression were allowed. The study was designed to assess absolute improvement in the 2-year disease-free survival rate compared with the short-term androgen suppression arm in Radiation Therapy Oncology Group (RTOG) study 92-02. RESULTS: Thirty-seven patients received a total of 72 hyperthermia treatments. The mean cumulative equivalent minutes (CEM) T90 43°C was 8.4 minutes. According to the 1992 AJCC classification, there were 19 patients with T2b tumors, 8 patients with T2c tumors, 5 patients with T3a tumors, and 5 patients with T3b tumors. The median Gleason score was 7 (range, 6-9), and the median prostate-specific antigen (PSA) level was 13.3 ng/mL (range, 2-65 ng/mL). Thirty-three patients received androgen suppression. At a median follow-up of 70 months (range, 18-110 months), the 7-year overall survival rate was 94%, and 61% of patients remained failure free (according to the American Society for Therapeutic Radiology and Oncology definition for failure free survival). The absolute rate of disease-free survival at 2 years, which was the primary study endpoint, improved significantly (84%) compared with a rate of 64% for similar patients on the 4-month androgen suppression arm of RTOG 92-02. When Phoenix criteria (PSA nadir + 2 ng/mL) were used to define biochemical failure, 89% of patients were failure free at 2 years. CONCLUSIONS: Hyperthermia combined with radiation for the treatment of locally advanced prostate cancer appeared to be promising. The current results indicated that further study of hyperthermia for the treatment of prostate cancer with optimal radiation and systemic therapy is warranted.

Hyperthermia combined with radiation in treatment of locally advanced prostate cancer is associated with a favourable toxicity profile.

PURPOSE: Hyperthermia is used to treat several pelvic tumours. An important step in establishing a broader role for hyperthermia in treatment of prostate cancer is verification of an acceptable toxicity profile. In this report, short- and long-term toxicity profiles of a completed phase II trial of transrectal ultrasound hyperthermia combined with radiation in treatment of locally advanced prostate cancer are presented. METHODS AND MATERIALS: Thirty-seven patients enrolled on a phase II study of external beam radiation +/- androgen suppression with two transrectal ultrasound hyperthermia treatments were assessed for short- and long-term toxicity. Prostatic and anterior rectal wall temperatures were monitored. Rectal wall temperatures were limited to 40 degrees C (19 patients), 41 degrees C (three patients) and 42 degrees C (15 patients). Univariate logistic regression was used to estimate the log hazard of developing NCI CTC Grade 2 toxicity based on temperature parameters. Hazard ratios, 95% confidence intervals, p-values for statistical significance of each parameter and proportion of variability explained for each of the parameters were calculated. RESULTS: Median follow-up was 42 months. Both short- and long-term GI toxicity were limited to grade 2 or less. Acute grade 2 proctitis was greater for patients with allowable rectal wall temperature of >40 degrees C. Eleven of 18 patients in this group had acute grade 2 proctitis vs three of 19 patients with rectal wall temperatures limited to 40 degrees C (p = 0.004). Long-term grade 2 GI and GU toxicity occurred in 5% and 19% of patients. No late grade 3 or greater toxicity occurred. Late GI and GU toxicity were not associated with the allowable rectal wall temperature. CONCLUSION: Transrectal ultrasound hyperthermia combined with radiation for treatment of advanced clinically localized prostate cancer is safe and well tolerated.

MammoSite and interstitial brachytherapy for accelerated partial breast irradiation: factors that affect toxicity and cosmesis.

BACKGROUND: In interstitial brachytherapy (IB), cosmesis and toxicity correlate with volume of tissue irradiated, dose homogeneity index (DHI), and adjuvant doxorubicin/cyclophosphamide based chemotherapy (ACCT). MammoSite brachytherapy (MSB) irradiates smaller volumes than IB, and lower dose homogeneity does not appear to affect toxicity. However, clinical experience suggests that other factors may also play an important role in cosmesis and toxicity with MSB. We reviewed our prospectively maintained data base of women who underwent accelerated partial breast irradiation (APBI) to assess this issue. METHODS: Beginning in September 1995, 115 women were enrolled in a trial evaluating APBI as monotherapy after lumpectomy. The first 75 eligible patients received IB, and the most recent 28 eligible patients received MSB. All patients received 34 gray (Gy) in 10 twice-daily fractions through high-dose rate iridium-192 brachytherapy; 19% of patients in the IB group and 0% of patients in the MSB group received ACCT. RESULTS: At 1 year after treatment, MSB caused significantly less Grade 2-4 subcutaneous fibrosis (as graded by a radiation oncologist according to the Radiation Therapy Oncology Group/Eastern Cooperative Oncology Group system) compared with IB (10.7% vs. 32%; P = 0.04). However, when only ACCT-naïve patients in the IB group were compared with patients in the MSB group, this finding became nonsignificant. Among the patients who received MSB, significantly smaller volumes were irradiated, and the DHI was lower. CONCLUSIONS: Current studies suggest an improved toxicity profile with MSB compared with IB that is attributed to lower irradiated volumes with MSB. When only chemotherapy-naïve patients were compared, however, toxicity and cosmesis were found to be similar between MSB and IB, suggesting a more complex interplay between irradiated volumes, DHI, and chemotherapy. The relation of ACCT to toxicity in this scenario is intriguing and warrants further investigation.

Association of rectal toxicity with thermal dose parameters in treatment of locally advanced prostate cancer with radiation and hyperthermia.

PURPOSE: Although hyperthermia has been used for more than two decades in the treatment of pelvic tumors, little is known about the potential impact of heat on rectal toxicity when combined with other treatment modalities. Because rectal toxicity is a concern with radiation and may be exacerbated by hyperthermia, definition of the association of thermal dose parameters with rectal toxicity is important. In this report, we correlate rectal toxicity with thermal dose parameters for patients treated with hyperthermia and radiation for prostate cancer. METHODS AND MATERIALS: Thirty patients with T2b-T3b disease (1992 American Joint Committee On Cancer criteria) enrolled in a Phase II study of external beam radiation +/- androgen-suppressive therapy with two transrectal ultrasound hyperthermia treatments were assessed for rectal toxicity. Prostatic and anterior rectal wall temperatures were monitored for all treatments. Rectal wall temperatures were limited to 40 degrees C in 19 patients, 41 degrees C in 3 patients, and 42 degrees C in 8 patients. Logistic regression was used to estimate the log hazard of developing National Cancer Institute Common Toxicity Criteria Grade 2 toxicity based on temperature parameters. The following were calculated: hazard ratios, 95% confidence intervals, p values for statistical significance of each parameter, and proportion of variability explained for each parameter. RESULTS: Gastrointestinal toxicity was limited to Grade 2. The rate of acute Grade 2 proctitis was greater for patients with an allowable rectal wall temperature of >40 degrees C. In this group, 7 of 11 patients experienced acute Grade 2 proctitis, as opposed to 3 of 19 patients in the group with rectal wall temperatures limited to 40 degrees C (p = 0.004). Preliminary assessment of long-term toxicity revealed no differences in toxicity. Hazard ratios for acute Grade 2 proctitis for allowable rectal wall temperature, average rectal wall Tmax, and average prostate Tmax were 9.33 (p = 0.01), 3.66 (p = 0.03), and 2.29 (p = 0.08), respectively. A model combining these three parameters explained 48.6% of the variability among groups. CONCLUSION: Rectal toxicity correlates with maximum allowable rectal wall temperature, average rectal wall Tmax, and average prostate Tmax for patients undergoing transrectal ultrasound hyperthermia combined with radiation for treatment of advanced clinically localized prostate cancer. Further definition of this association of thermal dose parameters with rectal toxicity in treatment of pelvic malignancies with hyperthermia should advance the goal of delivering thermal therapy in an effective yet safe manner.

Respiratory maneuvers decrease irradiated cardiac volume in patients with left-sided breast cancer.

Late cardiac morbidity and mortality among left breast cancer survivors treated with radiation therapy is related to cardiac volume included in the radiation portals. To determine if respiratory maneuvers can help decrease cardiac volume included in the radiation portals for left-sided breast cancer, 17 women with breast cancer, who had undergone left breast radiation therapy, underwent cardiac magnetic resonance imaging (MRI). Cardiac volume within the radiation portals was assessed from a transverse stack of eight, 10-mm thick, contiguous slices, covering the entire heart and obtained during breathholding at (1) endtidal volume (ETid) and (2) deep inspiration. Fourteen subjects (93% of those who completed the study) had inclusion of at least a portion of their heart within the radiation portals at ETid (median: 25.9 cm3, range 4.2-119.1 cm3). In all subjects, inspiratory breathholding decreased irradiated cardiac volume [median change: -18.1 cm3 (-49%), p < or = 0.001 vs. ETid]. In 21% of patients, the entire heart could be displaced outside the radiation field with deep inspiration. Age was not correlated with change or percentage change in cardiac volume with respiratory maneuvers. We conclude that in breast cancer patients, deep inspiratory maneuvers significantly decrease irradiated cardiac volume included in the left breast radiation field. Such an approach during delivery of radiation therapy allows preservation of radiation dosage to the breast, while reducing cardiac involvement and possible associated cardiovascular toxicity.