bluuebunny/crossref_metadata_2025_split huggingface dataset:
Overall survival (OS) and safety of dasatinib/docetaxel versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC): Results from the randomized phase III READY trial.
Authors: Araujo John C. , Trudel Geralyn C. , Saad Fred , Armstrong Andrew J. , Yu Evan Y. , Bellmunt Joaquim , Wilding George , McCaffrey John , Serrano Sergio V. , Matveev Vsevolod , Efstathiou Eleni , Oudard Stephane , Morris Michael J. , Sizer Bruce , Goebell Peter J. , De Bono Johann Sebastian , Paliwal Prashni , Durham Susan , Cheng Shinta , Logothetis Christopher 
Published: February 2017

LBA8 Background: SRC kinases may contribute to androgen independence of mCRPC.Dasatinib (DAS) inhibits tyrosine kinases including SRC kinases with preclinical evidence for antimetastatic activity, inhibition of osteoclast function in tumor microenvironment, and synergistic activity with docetaxel (D). In phase I/II trials of mCRPC patients (pts), DAS in combination with D had an acceptable safety profile with objective response rates (ORR) improved over historical data and decreased levels of bone turnover markers. Methods: READY was a multinational, randomized, double-blinded, placebo-controlled, phase III study. Pts with mCRPC (n = 1,522) were randomized (1:1) to receive either D 75 mg/m2q3wk + prednisone with double-blinded DAS 100 mg qd (DAS/D, n = 762) or placebo (PBO/D, n = 760). Primary endpoint was overall survival (OS). Secondary endpoints were ORR, time to first skeletal-related event (TFSRE), time to prostate-specific antigen progression (TPSAP), urinary N-telopeptide (uNTX) reduction, pain reduction, progression-free survival (PFS), and safety. Results: No OS difference between DAS/D and PBO/D (median, 21.5 vs. 21.2 mos; hazard ratio [HR], 0.99; log-rank P = 0.90) was observed. Results of secondary endpoints for DAS/D vs. PBO/D were: ORR (30.5 vs. 31.9%); TFSRE (median, not reached vs. 31.1 mos; HR, 0.81 [95% CI, 0.64-1.02]); uNTX reduction (66.0 vs. 60.6%); PFS (median, 11.8 vs. 11.1 mos; HR, 0.92); TPSAP (median, 8.0 vs. 7.6 mos; HR, 0.91), and pain reduction (66.6 vs. 71.5%). Twenty-three percent of DAS/D and 14% of PBO/D pts received therapy for <3 mos. Most common AEs in DAS/D arm included diarrhea, fatigue, alopecia, and nausea. Grade 3-4 AEs of interest for DAS/D vs. PBO/D included anemia (8.0 vs.5.9%), neutropenia (6.2 vs. 5.5%), hypocalcemia (3.5 vs.3.1%), GI bleeding (2.6 vs.1.3%), and pleural effusion (1.3 vs. 0.4%). Conclusions: The addition of DAS to standard-of-care chemotherapy in mCRPC pts did not improve OS. There was a modest reduction in the risk of TFSRE with DAS/D vs. PBO/D. With a median follow-up of 19 mos of 761 DAS/D-treated pts, no unexpected toxicities for DAS were observed. Clinical trial information: NCT00744497.
E1308: Reduced-dose IMRT in human papilloma virus (HPV)-associated resectable oropharyngeal squamous carcinomas (OPSCC) after clinical complete response (cCR) to induction chemotherapy (IC).
Authors: Cmelak Anthony , Li Shuli , Marur Shanthi , Zhao Weiqiang , Westra William H. , Chung Christine H. , Gillison Maura L. , Gilbert Jill , Bauman Julie E. , Wagner Lynne I. , Ferris Robert L. , Trevarthen David R. , Colevas A. Dimitrios , Jahagirdar Balkrishna N. , Burtness Barbara 
Published: February 2017

LBA6006 Background: HPV+ patients (pts) in E2399 obtained a 2-yr 95% survival and 86% PFS after IC and 70Gy chemoradiation. We hypothesized reduced-dose IMRT (54Gy, 23% reduction) in HPV+ OPSCC pts could maintain high LR control and 85% 2-yr PFS in pts with cCR to IC. Methods: Pts with resectable stage III/IVa,b HPV+ OPSCC received IC q3 weeks x 3 with paclitaxel 90mg/m2 days (D) 1,8,15, cisplatin 75mg/m2 D1, and standard cetuximab (Cetux) weekly schedule. IC response determined IMRT dose independently at primary and involved nodes: IMRT 54Gy/27 if cCR vs. 69.3Gy/33 if <cCR. Cetux was continued during IMRT. Primary endpoint was 2-yr PFS. Results: 90 pts were enrolled (80 analyzable). Med FU is 23.3 months (mo). Tumor and Nodal stage: T4-10%, T3-17%, T2-50%, and T1-23%; N0,1-16%, N2a,b-54%, N2c-31%. Med age 57yrs. 46% never smoked and 84% not current smokers. IC and C-IMRT was well tolerated: 96% received all 3-cycles of IC. 71% had cCR. 62 pts (78%) received reduced-dose Cetux-IMRT. For all reduced IMRT pts, 23mo PFS is 84%, primary site LC 94%, nodal control 95%, and distant 92%. Post-treatment neck dissection was positive for tumor in 4/8 reduced dose IMRT pts compared to 1/3 pts treated with std dose. One late grade 3 toxicity occurred in 1 reduced-dose pt: hypomagnesemia at 30mo. Conclusions: IC + reduced-dose Cetux-IMRT produced high tumor control rates. Late toxicities were minimal. Low dose pts achieved 84% PFS at 23mo and 95% 2-yr survival. Pts with <10yrs smoking, T1-3 and N0-2b disease achieved 96% PFS. Further studies of reduced-dose IMRT in chemoresponsive HPV+ pts are warranted. Clinical trial information: NCT01084083. [Table: see text]
Shear-wave elastography in detection of residual breast cancer after neoadjuvant chemotherapy.
Authors: Lee Su Hyun , Chang Jung Min , Cho Nariya , Moon Woo Kyung 
Published: February 2017

102 Background: To evaluate the accuracy of shear-wave elastography (SWE) in detecting residual cancer after neoadjuvant chemotherapy. Methods: This retrospective study was approved by our institutional review board and the requirement for written informed consent was waived. From January 2012 to February 2013, 71 women with stage II-III invasive breast cancers who received neoadjuvant chemotherapy and were imaged with B-mode ultrasonography (US), SWE, and magnetic resonance (MR) imaging before surgery were included. Presence of residual cancer was evaluated and categorized according to the morphology on preoperative B-mode US and MR imaging. Quantitative elasticity values (maximum kPa) were acquired for primary lesions depicted on US. Pathological complete response (pCR) was defined as no residual invasive cancer cells. The quantitative SWE values were compared between the pCR and non-pCR group using independent samples t-test. The areas under the receiver operating characteristics curve (AUC), sensitivities, and specificities of B-mode US, MR, and SWE for detecting residual cancer were compared, with histopathologic examination as the reference standard. Results: Of the 71 women, 15 (21%) achieved pCR. The mean size of residual invasive cancers was 2.2 cm (range 0.1-6.4 cm).The maximum SWE value was significantly higher in the non-pCR group (mean, 122.9 kPa) than in the pCR group (30.6 kPa) (P < 0.001). The AUC of SWE for detecting residual cancer (0.893) was higher than that of B-mode US (0.684) (P = 0.001) and comparable to that of MR (0.884) (P = 0.825). The optimal cut-off value, yielding the maximal sum of sensitivity and specificity, was 98.1 kPa, and the sensitivity and specificity of SWE at that cut-off value were 66% (37 of 56) and 100% (15 of 15). When SWE was added to B-mode US, the AUC value was significantly increased to 0.830 (P = 0.039). Conclusions: SWE was accurate in the detection of residual cancer after neoadjuvant chemotherapy. When SWE was combined with B-mode US, the accuracy was significantly improved.
Outcomes for APBI with strut-based brachytherapy: First 100 accrued patients (5-year median follow-up).
Authors: Kuske Robert R. , Quiet Coral , Snyder Margaret B. , Lyden Maureen , Attai Deanna J. , Komarnicky Lydia T. , Reiff Jay E. , Mantz Constantine , Finkelstein Steven E. , Scanderbeg Daniel , Yashar Catheryn M. 
Published: February 2017

114 Background: The SAVI Collaborative Research Group (SCRG), was created to study the long-term outcomes of women receiving accelerated partial breast irradiation (APBI) using strut-based applicators. The outcomes for the first 100 accrued patients in the study are reported. Methods: Patients for this subset analysis weretaken as the initial 100 treated across all participating sites. Median follow-up of this cohort was 56.3 months at the time of the abstract. Patients were treated with APBI using the strut-based brachytherapy device with conventional dose and fractionation (3.4 Gy x 10 fx, BID). Treatment planning goals for the planning target volume were a V90>90%, V150<50 cc, and V200<20 cc. Patients were followed regularly by their radiation oncologist and outcomes were graded based on the CTCAE v3.0 (common terminology criteria for adverse events, version 3.0). Recurrence (raw and actuarial) rates were also calculated based on the follow up. Cosmesis was graded using the Harvard Scale. Results: 75 patients had invasive disease and 25 had ductal carcinoma in situ. The median age was 60.5 yrs (range 40-85 yrs), with 84% post-menopausal. Median tumor size was 10.0 mm (range 0.7-35 mm) with 92% being estrogen receptor positive. 65% of patients had at least one round of hormone therapy and 7% had chemotherapy. All patients completed APBI as planned with no serious adverse events. All patients met the dosimetric criteria. Good/excellent cosmesis was seen in >94% of subjects at all times of follow up (6-60 months). The 5-yr actuarial rates for TR/MM were 2.2%, 1.5% and 4.2% for all subjects, invasive and DCIS subgroups, respectively. The 5-yr actuarial rates for IBTR were 3.3%, 3.0% and 4.2% for all subjects, invasive and DCIS subgroups, respectively. Conclusions: For these initially treated 100 patients with a median 5 years of follow up, strut-based brachytherapy appears to be a well-tolerated, effective treatment with low rates of toxicities and local control as good as other brachytherapy APBI methods.
Cancer-related distress and unmet needs among members of a metastatic breast cancer registry.
Authors: Buzaglo Joanne S. , Miller Melissa F , Morris Anne , Harvey Allison , Golant Mitch 
Published: February 2017

118 Background: An estimated 155,000 people are living with metastatic breast cancer (MBC) in the US. Emotional distress among people living with MBC is common; yet, little is known about the patient experience and distress screening. Methods: Since March 2013, the Cancer Support Community has registered 909 people living with MBC to the Cancer Experience Registry, an online initiative that is designed to raise awareness about the psychosocial impact of cancer. 599 registrants responded to questions about cancer related distress. This sample was 99% female, 91% Caucasian, and 69% with a college degree and median age 56. Median time since MBC diagnosis was 3 years. Results: The top sources of distress (% rated seriously or very seriously concerned) were: (1) worry about the future (44%); (2) fatigue (39%); (3) health insurance or money worries (38%). 49% reported fatigue was ‘quite a bit’ or ‘very much’ disruptive in their life and 46% reported intrusive ideation about the financial cost of care. Factors that were independently associated with greater overall distress included younger age (p<0.001), higher comorbidity (p<0.001), lower income (p=0.001). 43% of respondents were never asked about distress by their health care team. Those who received all or part of their treatment in an academic or comprehensive cancer center were significantly more likely to be asked about distress versus those receiving treatment anywhere else (65% vs. 50%, p=0.002). Among those who were asked about distress (n=340), 62% received referrals to manage distress within their health care system, and 19% at a community-based organization; 47% reported their health care team helped coordinated distress-related care. 20% of those asked about distress never received referrals for managing it. Conclusions: These findings support the need for integrated supportive care services and better side-effect management. Disturbingly, 20% of patients who asked for referrals never received them and only 19% of patients were referred to community-based organizations for treating their distress where these services are often provided at low or no-cost. There is an on-going need for coordinated care that integrates programs and services across health care systems.
Assessment of the effectiveness of survivorship care in breast cancer patients.
Authors: Dietrich Leah L. , Al-Hamadani Mohammed , Meyer Chris , Watral Alexandra , Smith Angela 
Published: February 2017

123 Background: After the IOM report “From Cancer Patient to Cancer Survivor - Lost in Transition” was issued, there was a widespread call to develop Survivorship programs. Few studies have evaluated the effectiveness of these programs. Prior studies have focused on perceptions of, or preferences for, certain models of survivorship care. Therefore, our goal was to retrospectively evaluate our effectiveness based on patient perception, quality of life (QOL) and compliance with NCCN guidelines for follow-up. Methods: Eligible patients completed all of their breast cancer treatment at GHS. Surveys were sent out to evaluate patient knowledge and QOL. Chart review was conducted to assess NCCN compliance. Survivorship clinic attendees and non-attendees were matched for age and disease stage for comparison purposes of the outcomes (QOL, NCCN compliance, overall effectiveness) using descriptive statistics analysis. Chi-squares and t-tests/ANOVA statistical tests were used for categorical and continuous data significance respectively. Results: We found survivorship clinic patients (n=65) tended to perceive their concerns, in various categories, to be more adequately addressed than non-attendees (n=52), with significant differences in the areas of practical concerns and questions regarding late-term side effects. Categories in which there were no significant differences tended to be highly rated in both groups. There was also a significant difference in compliance with two NCCN guidelines for those attending survivorship. Additionally, women attending the survivorship appointment utilized supportive resources more than those who did not attend. Conclusions: Survivorship clinic attendees felt certain concerns were better addressed, were more compliant with NCCN recommended follow-up, and used supportive services more often than non-attendees. Statistically significant differences in other categories may be found in a larger sample size. These measures can be used to help us improve our survivorship services and for other institutions to measure quality and effectiveness of their programs.
Selective versus routine use of pegfilgrastim in dose-dense chemotherapy.
Authors: Pass Alexandra R. , Lo Caylin , Bishop Jennifer , Lo K. M. Steve 
Published: February 2017

149 Background: ASCO recommends CSFs such as pegfilgrastim for dose dense doxorubicin cyclophosphamide paclitaxel (ddACT) in breast cancer. It is unclear whether dose dense paclitaxel requires pegfilgrastim, and some community oncologists use pegfilgrastim selectively with the dose dense paclitaxel portion of ddACT. We reviewed the results of pegfilgrastim use based on physician preference within a single breast oncology community-based practice. Methods: This is a single-center, single-practice retrospective cohort study of adjuvant ddACT for breast cancer patients identified from the pharmacy database between 1/2010 and 6/2014. Patient demographics, stage, chemotherapy and pegfilgrastim use, chemotherapy delays, febrile neutropenic (FN) events, and pain records including narcotic use were collected from patient charts. Patients receiving pegfilgrastim routinely at cycle 1 were compared to those within the practice given pegfilgrastim selectively for ANC < 1.5 on day of treatment or nadir ANC < 1.0 during the preceding cycle. Differences between groups were analyzed using the Mann-Whitney test, with significance at the p < 0.05 level. Results: The two groups were balanced with regard to age and number of cycles. There were no significant differences in cycle delay, and FN. Routine pegfilgrastim resulted in more bone pain and higher cost. Conclusions: The selective use of pegfilgrastim during the paclitaxel portion of ddACT did not result in chemotherapy delay, more infections or FN. It did decrease painful myalgia and arthralgias, and dramatically lowered treatment cost. These retrospective data, although limited by participant number, question the need for the routine use of pegfilgrastim for the paclitaxel portion of ddACT and require prospective validation. [Table: see text]
Detection of metastases in breast cancer: Is whole body PET/MR better than PET/CT?
Authors: Teplinsky Eleonora , Pujara Akshat , Esteva Francisco J. , Moy Linda , Melsaether Amy , Jhaveri Komal L. 
Published: February 2017

15 Background: Whole body PET/CT is commonly utilized in breast cancer (BC) patients (pts). Limitations include assessment of treatment response in bone metastases (mets), high physiologic uptake in brain and liver, and cumulative radiation exposure. The site of mets can have prognostic and therapeutic implications. PET/MR, an exciting new hybrid technology, delivers less radiation than PET/CT. Our aim was to compare the differences in metastatic lesion detection using PET/CT & PET/MR in all BC subtypes. Methods: After a single 18-FDG injection, pts had whole body PET/CT for staging and assessment of treatment response. They were transported to another NYU facility & then underwent whole body PET/MR. PET/MR & PET/CT images were each read by a radiologist blinded to prior exams or reports. Number of mets (up to 6) per organ was recorded. 2 experienced radiologists unblinded to imaging and pathology reports served as the “reference standard”. Results: Forty-eight BC pts underwent PET/CT & PET/MR (28 in metastatic setting, 5 for staging & 15 to rule out recurrence). Median age: 55; range 32-79 with 31 ER+/HER2-, 8 ER+/HER2+, 2 ER-/HER2+, 6 ER-/HER2+, 1 unknown. 20 pts had no distant mets on scan. In the remaining 28 pts, the reference standard detected 9 liver, 18 bone, 7 lung/pleura, 5 brain & 10 lymph node (LN) metastases; some patients had ≥1 metastatic site. PET/CT had more false positives (FP) and false negatives (FN) in the detection of mets (Table). PET/MR had 1 FP in the liver. PET/MR accurately detected 2 bone (ER+/HER2-), 3 liver (ER+/HER2-), 2 LN (1 ER+/HER2+; 1 ER+/HER2-) and 5 brain lesions (1 ER+/HER2-; 3 ER-/HER2+; 1 ER+/HER2+) in 10 unique pts that were not identified on PET/CT. 1 liver (ER+/HER2-) and 2 brain mets (ER-/HER2+) identified on PET/MR were previously unknown. Conclusions: Our preliminary data suggest that PET/MR outperformed PET/CT in detecting mets in the liver, brain, LN & possibly bone. Prospective studies of PET/MR are warranted to determine whether early detection of mets, including occult brain mets in HER2+ pts, impacts survival.[Table: see text]
The role of adjuvant chemotherapy in luminal B breast cancer.
Authors: Zhao Meng , Zhang Jianying , Laubacher Janette S , Ramirez Maria-Teresa , Shapiro Charles L. 
Published: February 2017

156 Background: Luminal B breast cancer is a heterogeneous subtype characterized by higher grade, increased proliferation rates and overall poorer prognosis. We conducted a retrospective study on the associations between adjuvant chemotherapy, HER2 overexpression, progesterone receptor (PR) and treatment outcomes. Methods: The characteristics of 1,372 patients (pts) with ER positive (ER+) breast cancer (stages 1-3) diagnosed between 1998 and 2005 were reviewed. 432 (31%) were phenotypically defined as luminal B: (2011 St. Gallen’s consensus criteria): ER+, HER2-negative (HER2-) and histological grade 3, or ER+ and HER2-positive (HER2+). ER and PR was positive if nuclear staining was > 1%. HER2 was positive if IHC = 3+ or gene amplification was confirmed by FISH. Statistical analyses were performed using Kaplan-Meier estimate and multivariable cox regression. Results: Among the 432 luminal B pts, 179 cases (41%) were HER2+ and 93 (22%) were PR negative (PR-). Tumor characteristics were similar (see Table). With a median follow-up of 105 months the overall recurrence rate was 56/432 (13%) pts and the median disease-free survival (DFS) and overall survival (OS) have not been reached. No differences were observed in DFS or OS between HER2+ and HER2- groups or between PR+ and PR- groups. In multivariate analysis, Pts who received adjuvant chemotherapy had better DFS (HR = 0.3, p = 0.034) and OS (HR = 0.2, p = 0.013) and the benefit of adjuvant chemotherapy was not dependent on HER2 overexpression (DFS: HR = 1.65, p = 0.37; OS: HR = 1.65, p = 0.39) or PR status (DFS: HR = 1.8, p = 0.37; OS: HR = 2.3, p = 0.25). HER2+ in pts ≥ age of 60 (presumed postmenopausal) was associated with worse DFS (HR = 3.23, p = 0.017) and OS (HR = 3.06, p = 0.027). Conclusions: In patients with luminal B subtype adjuvant chemotherapy significantly improved OS and DFS irrelevant of HER2 or PR status. HER2+ was a poor prognostic factor in postmenopausal pts, however, the vast majority of them did not receive adjuvant trastuzumab. [Table: see text]
Influence of hormone receptor status on survival in male breast cancer: A SEER database analysis.
Authors: Adekolujo Orimisan Samuel , Mistry Shams Aziz , Saxena Nishkarsh , Schmidt Marcello , Subbaiah Perla , Ehwarieme Rukevwe , Arora Madan L. , Kakarala Radhika 
Published: February 2017

158 Background: In female breast cancer, estrogen receptor (ER) and/or progesterone receptor (PR) positivity confers a favorable prognosis; however, the effect of these hormone receptors (HR) on survival in male breast cancer (MBC) is controversial. The aim of this study isto determine if there is a difference in the 5 year cancer specific survival (CSS) rate of patients in different HR subgroups of MBC using the SEER database. Methods: We included patients with MBC ≥ 18 years of age in the SEER database from 1990 to 2011. Patients with unknown or borderline ER or PR status were excluded. Patients were divided into four subgroups based on HR status: ER+/PR+, ER+/PR-, ER-/PR+, ER-/PR-. Univariate analysis was done using t-test and chi-square. Multivariate Cox regression analysis was used to evaluate hazard ratios and determine the significance of covariates. Kaplan -Meier method was used to estimate survival. Results: We included 3,341 patients. The mean age was 64.9 years (SD 12.7) and most (2736, 81.9%) were Caucasians. The majority (2770, 82.9%) had ER+/PR+ tumors, 377 (11.3%) had ER+/PR- , 33 (1.0 %) had ER-/PR+ and 161(4.8%) had ER-/PR- tumors. Caucasians were more likely to have MBC positive for both ER and PR compared to African-Americans (84.1% versus 74.3%, P< 0.001). ER-/PR- tumors were more likely to be poorly differentiated compared to ER+/PR+ , ER+/PR- and ER-/PR+ (62.7%, 32.2%, 44.8%, 36.4% respectively , P<0.001). There was a significant difference in 5 year CSS of HR subgroups only in stage III and IV, with subgroups positive for ER consistently showing improved survival compared to ER-/PR- (Table). On multivariate analysis, positive ER or PR status was independently associated with decreased hazard of death (Hazard Ratio: 0.68 (p = 0.03); 0.78 (p = 0.04) respectively). Conclusions: Our study showed a significant difference in the 5 year CSS rate of patients in different HR subgroups of advanced stages (III and IV) of MBC. Positive HR status was associated with a better prognosis. [Table: see text]