tbuckley/cabot-search huggingface dataset:
Interleukin-2 (IL-2) and 5-(3,3-dimethyle-1-triazeno) imidazole-4-carboxamide (DTIC) for adjuvant therapy in resected high-risk primary and regionally metastatic melanoma.
Authors: Rahul Gosain, Amitoj Gill, Hana Gragg, Ryan Glenn Bycroft, Shesh Rai, Jianmin Pan, Jason Alan Chesney, Donald M. Miller
Journal: Journal of Clinical Oncology (2017)

e21076 Background: High-dose interferon (IFN) and ipilimumab currently are the only approved adjuvant therapies for high-risk melanoma patients. We analyze the recurrence free survival (RFS), overall survival (OS), and toxicity profile of Interleukin-2 (IL-2) and 5-(3,3-Dimethyle-1-Triazeno) Imidazole-4-Carboxamide (DTIC) combination for resected high-risk primary and regionally metastatic melanoma patients as an alternative adjuvant therapy. Methods: Patients with stage IIB, IIC and stage III melanoma that were treated and received adjuvant IL-2/DTIC combination therapy at a single institution in the year 2000 to 2010 were retrospectively reviewed. No evidence of residual disease was noted prior to therapy. Regimen consisted of subcutaneous IL-2 at 12 x 10 6 units on days 1 through 4 every month and DTIC 750mg/m 2 on day 1 of each cycle every 28 days for 6 cycles. Individual medical records were accessed to collect the data and the Kaplan-Meier method was used to estimate RFS and the OS. Results: Of the 112 patients included, all underwent surgery and then received adjuvant treatment. 109 patients were followed and 3 were lost to follow-up. 59% of the patients were male, 41% were female. 79 (70.5%) of the patients were alive at the time of analysis and 57 patients were currently event free. 69 (61.61%) of the patients completed all 6 months of adjuvant combination treatment with 22.3% of the patients requiring DTIC and 15.2% of the patients’ required IL-2 dose reduction. 2-year OS (from the day of surgery) was 92.85% (95% CI of 86.29-96.53) with RFS of 66.31% (95% CI of 56.92-74.49) and 5-year OS was 75.57% (95% CI of 64.72-83.50) with RFS of 53.05% (95% CI of 41.91-62.58). Conclusions: With little improvement in the RFS from IFN and high toxicity profile with ipilimumab, neither of these treatment regimens seem to be an ideal option. In our retrospective analysis, combination therapy with IL-2/DTIC appears to be beneficial and well tolerated as an alternative adjuvant treatment for patients with high-risk melanoma, but this observation requires further prospective validation.
Pegylated liposomal doxorubicin (PLD) as an active treatment option for desmoid tumor (DT) patients.
Authors: Angela Pang, Daniela Venancio Gouveia Macedo, Mariana Carbini, Robert G. Maki
Journal: Journal of Clinical Oncology (2016)

11032 Background: Aggressive fibromatoses (desmoid tumors, DT) are locally aggressive connective tissue tumors prone to local recurrences. There is a thin line between the morbidity of aggressive surgical resection and tumor growth during watchful waiting, particularly so for intra-abdominal DT. There remain relatively few data regarding anthracycline (ANTH) therapy in DT. We review the experience at our institution of DT pts treated with ANTHs, focusing on PLD and doxorubicin (ADR). Methods: 132 pts with DT were treated at our center (2003-15). 26 pts (20%) had FAP and diffuse mesenteric DT, while the rest were sporadic. 65 pts (49%) received at least 1 line of systemic therapy (NSAIDs, hormonal therapy or other systemic agents). 36 pts (27%) received 39 courses of ANTH-based therapy containing ADR or PLD. Results: Of the 36 ANTH-treated DT pts, 29 received PLD and 6 received ADR-based therapy (3 as monotherapy); 1 pt was treated with ADR then PLD in separate courses. Median follow-up was 39 months. CT reimaging was typically performed every 3-4 months on therapy. Most pts started 40mg/m2 PLD or 60-75mg/m2 of ADR per cycle. 9/36 pts (25%) required dose reductions (all PLD pts) and 5 pts (14%) stopped therapy, 2 from anaphylactoid reaction, 2 with transient drop in EF and 1 from G3 hand-foot syndrome. Median treatment duration for 31 evaluable ANTH-treated pts was 5.6 months. 26/27 PLD pt courses were evaluable by RECIST 1.1; 1 (4%) had a complete response (CR), 10 (39%) had a partial response (PR), 10 (38%) had stable disease (SD) and 5 (19%) had disease progression (PD). For all ANTH pts, 31/36 pts were RECIST 1.1 evaluable; 1 (3%) had a CR, 11 (36%) had a PR, 13 (42%) had SD and 6 (19%) had PD. The median PFS of these 31 evaluable pts was 41.6 months (SE 18.5 months); 15/36 pts (42%) had not progressed at the time of this analysis. Conclusions: These data confirm prior experience showing PLD as active in DT. Systemic therapy with ANTH remains a viable option in place of morbid surgery for symptomatic DT pts.
Abstract 17796: Development of Computational Simulation of Pulmonary Autograft Remodeling After Ross Procedure
Authors: Yue Xuan, Ismail El-Hamamsy, Francois Pierre-Mongeon, Richard Leask, Elaine E Tseng, Liang Ge
Journal: Circulation (2016)

Introduction: Ross operation is advantageous to avoid anticoagulation and provide growth for children and young adults. Clinical outcomes have shown excellent hemodynamics, and restoration of norma...
Miami NICE trial: Nutritional support for patients incurring chemotherapy side effects.
Authors: Damien Mikael Hansra, Catherine Diaz, Skip Camp, Caroline Randolph, Christine Norman-Tiner, Jorge Antunez de Mayolo
Journal: Journal of Clinical Oncology (2017)

6568 Background: Few studies have been performed addressing nutritional interventions &amp; mitigation strategies to address side effects such as weight gain, anorexia, dysgeusia, in patients (pts) undergoing chemotherapy. We aim to study the effect of nutritional counseling on body mass index (BMI) and other side effects in pts undergoing systemic chemotherapy. Methods: Prospective randomized study of 50 pts into two groups (A &amp; B). Group A was randomized to standard of care: oncologist visits once per month x 3 months, routine physician counseling &amp; dietary recommendations. Group B: standard of care + nutritionist intervention which included 3 visits x 30 mins each. Nutritionists performed an initial assessment of pts at the first session (template provided in poster) then tailored dietary counseling monthly x3 months which includes dietary strategies to mitigate side effects, pt &amp; caregiver education, recipes, &amp; handouts (provided in poster). Inclusions: medically insured male &amp; female adults with active malignancies (hematologic &amp;boncologic) on chemotherapy (neoajuvant, adjuvant, palliative). Exclusions: pts with head &amp; neck, stomach, esophagus, pancreatic tumors &amp; pts with pre-existing cachexia. Data collected: pt gender, age, race, ethnicity, cancer subtype, TNM staging, chemotherapy regimen. Primary objective: compare change in BMI at visit 1, 2, &amp;3. Secondary endpoints: anorexia, nausea, vomiting, depression, etc. reported in poster. Mean change in BMI, secondary endpoints compared using students T-test with ANOVA using SAS software version 8.0 &amp; minitab version 17. Results: Group A initial BMI = 28.85 vs group B initial BMI = 27.34 (p = 0.05). Change in BMI group A vs B at visit 1 (0.4 vs 0.09, p = 0.002), visit 2 (4.6 vs -0.52, p = 0.001), visit 3 (6.5 vs 0.46, p = 0.003). Demographics &amp; secondary endpoints reported in poster. Conclusions: We found dietary counseling in addition to standard of care was associated with significant mitigation of weight gain in patients on systemic chemotherapy. Dietary counseling is a relatively simple, inexpensive, individualized, &amp; reproducible method to mitigate chemotherapy related weight gain.
Preliminary results from an ongoing phase 2a study of RX-3117, an oral nucleoside analogue to treat advanced urothelial cancer (aUC).
Authors: Jacob Adashek, Sumanta K. Pal, Vincent M. Chung, Scott T. Tagawa, Joel Picus, Hani M. Babiker, Sumati Gupta, Raymond Couric Wadlow, Julie Poore, Christine Peterson, Ely Benaim
Journal: Journal of Clinical Oncology (2018)

4543 Background: RX-3117 is an oral small molecule nucleoside analogue (cyclopentyl pyrimidyl nucleoside) that is activated by uridine cytidine kinase 2. RX-3117 shows efficacy in various xenograft models, including those of gemcitabine resistant bladder cancer. Preliminary data from Stage 2 of a Phase 2a clinical study of RX‐3117 as a single agent in subjects with advanced urothelial cancer (aUC) is described below. Methods: The efficacy of oral RX‐3117 was evaluated in eligible patients (aged ≥ 18 years) with refractory aUC in a Phase 2a study. Primary objectives include safety and efficacy of 700 mg of administered orally RX‐3117 for 5 consecutive days followed by 2 days off per week in each 4-week cycle for 4 continuous weeks. The primary endpoint is a ≥ 20% rate of progression free survival (PFS) benefit (i.e., proportion of subjects with stable disease for at least 4 months) and/or 10% of evaluable patients with a partial or better response by RECIST criteria. Results: As of February 2018, 27 patients (19 males, 8 females) with aUC were treated with RX‐3117. The median age was 67 years and ECOG performance status was ≤ 1. Prior treatment with gemcitabine or immunotherapy was 85% or 67% of patients, respectively. Five patients achieved stable disease for 4 cycles of RX‐3117 treatment; one patient received treatment for 315 days and another patient continues treatment beyond 4 months. One patient achieved a partial response after 2 cycles. Four patients have shown a tumor reduction ranging from 13.9 to 20% as measured by RECIST. All reductions occurred after 1 cycle of RX-3117 treatment, except for one patient’s reduction, which occurred after 4 cycles. The most frequent related adverse events were G1/2 diarrhea (14%), fatigue (9%), nausea (9%), vomiting (9%), G1/G2 anemia (7%), and G3 thrombocytopenia (7%). Conclusions: RX‐3117 is safe and well tolerated and shows preliminary evidence of anti-tumor activity in heavily pretreated patients. The study continues to enroll subjects with aUC in Stage 2. Clinical trial information: NCT02030067.
Prophylactic anticoagulation to benefit younger patients under 65 years of age with metastatic lung cancer: An analysis of the 2013 Healthcare Cost and Utilization Project (HCUP) data.
Authors: Arindam Bagchi, Veena Iyer, Danae Hamouda, Qiang Nai, Sadik Khuder, Cherian Verghese
Journal: Journal of Clinical Oncology (2017)

6581 Background: Cancer patients have increased risk of venous thromboses. Venous thromboembolism (VTE) is reported to be a leading cause of death in cancer patients. It has been hypothesized that prophylactic anticoagulation for VTE might improve prognosis and quality of life. Based on our analysis of the 2013 HCUP data, we propose that prophylactic anticoagulation should be considered for patients younger than 65 years with metastatic lung cancer. Methods: Patients were selected using ICD-9 diagnoses codes for metastatic lung cancer and VTE. Diagnoses were stratified by site including upper extremity, lower extremity, pulmonary, abdominal and nonpulmonary thoracic VTE. Patients were stratified by age, sex, race and ethnicity. Differences in incidence of VTE among groups were calculated by the Chi-Square method using the SAS software. Results: There were a total of 16,577 VTE events amongst 182,863 cases of metastatic lung cancer. Subgroup analyses showed that patients younger than 65 years of age had 356.82 more PE events per 100,000 individuals compared to those at or older than 65 years (p &lt; 0.0001). The same age group also showed 374.83 more UE, 286.94 more nonpulmonary thoracic and 263.97 more abdominal (Abd) VTE events per 100,000 individuals (p-values, p &lt; 0.0001). There was no statistically significant difference in the incidence of LE VTE’s between the subgroups. Conclusions: Prophylactic anticoagulation should be considered in patients &lt; 65 years of age with metastatic lung cancer. Increased incidence of VTE in these patients may contribute towards greater morbidity and mortality associated with metastatic lung cancer in this subgroup. [Table: see text]
Necrotic Plaque on the Distal Nose With Diffuse Crateriform Nodules
Authors: Karlyn Pollack, Darren Guffey, Alejandro A. Gru
Journal: JAMA Dermatology (2018)

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Efficacy and tolerability of high dose interleukin-2 (HD IL-2) after disease progression on targeted therapy (TT) for metastatic renal cell carcinoma (mRCC).
Authors: Peter Vu, Hanh P. Mai, William Adams, Beverly Gonzalez, Stephanie Kliethermes‌, Joseph Clark, Elizabeth Henry
Journal: Journal of Clinical Oncology (2016)

e16064 Background: Approved first-line treatment for mRCC includes HD-IL2 and TT. TT is more commonly used given higher response rates, more favorable side effect profile, and oral administration. However, HD-IL2 can induce durable complete responses in 5-10% of pts. Limited data exists on the efficacy and tolerability of HD-IL2 when administered after disease progression on TT compared to no prior TT. Methods: All pts treated with HD-IL2 for mRCC from 2008-2015 at a single institution were reviewed and grouped by number of prior TT. Outcomes included response, overall survival (OS), progression free survival (PFS), and serious adverse events (SAE). Pt demographics, ECOG performance status (PS), number of doses, and death were captured. Response was defined using RECIST criteria. OS and PFS were estimated using Kaplan–Meier methods and compared using a Cox proportional hazards model. Results: A total of 101 pts received HD-IL2. First-line HD-IL2 was used in 83 of these pts. HD-IL2 after TT was used in 18 pts: 12 were treated after progression on 1 prior TT and 6 after progression on ≥ 2 TT. No significant differences in age, sex, or PS were observed between groups. Complete responses (CR) were observed in 12 pts (15%) and partial responses (PR) in 9 pts (11%) in the first-line HD-IL2 group. CR was observed in 1 pt (5%) and PR in 8 pts (44%) in the second-line HD-IL2 group. In both groups, CR was associated with more doses of HD-IL2 (35 vs 19, p = .002). There was no difference in OS or PFS when HD-IL2 was administered first-line or second-line or higher (p = 0.50; p = 0.32). Median duration of response was 18 mos (range: 0-123) with first-line and 16.5 mos (range: 2-91) with second-line or higher. No responses were seen in the 6 pts receiving HD-IL2 after ≥ 2 TT. There was no difference in Grade 4 or higher SAE between groups. Conclusions: In our sample, HD-IL2 after disease progression on TT was tolerated without excess toxicity and demonstrated similar responses, OS, and PFS to HD-IL2 administered first-line. However, pts previously treated with ≥ 2 TT did not respond to HD-IL2. Further investigation is warranted to determine if the use of HD-IL2 as third-line therapy is safe and effective.
Association of HIPEC with survival in patients with ovarian metastases of gastrointestinal origin.
Authors: Srividya Srinivasamaharaj, Dhruv Ranchhodbhai Chaudhary, Xiaoyong Wu, Shesh Rai, Mary Ann Sanders, Rebecca A. Redman
Journal: Journal of Clinical Oncology (2017)

e15124 Background: Metastatic ovarian involvement in primary gastrointestinal (GI) carcinomas (CA) is associated with a poor prognosis. We performed a survival analysis in patients with ovarian metastases, based on site of primary GI CA (appendiceal, colorectal (CRC), gastric, and pancreatic). We also examined the association between hyperthermic intraperitoneal chemotherapy (HIPEC) and death in these patients. Methods: A search was conducted in a single institution pathology database for patients with primary GI CA and ovarian metastases diagnosed from 2010 to 2017. The search yielded 39 patients, and data pertaining to tumor characteristics and treatment were obtained by chart review. Chi-square (log rank) test was used to test for associations between both site of primary GI CA and HIPEC, and death, and Kaplan-Meier analysis was done. P-value &lt; 0.05 was deemed statistically significant. Results: CRC accounted for the majority of patients (51.29%) with appendiceal CA accounting for 23.08% and gastric and pancreatic cancer making up the remainder. Primary site of malignancy was associated with survival (p = 0.036), favoring those with appendiceal and colorectal primaries. A total of 30 patients (76.92%) received HIPEC. Having undergone HIPEC was significantly associated with survival (p = 0.017). Conclusions: Ovarian metastases secondary to gastric and pancreatic cancer were associated with inferior survival as compared to those with appendiceal or colorectal primaries. A significant association was demonstrated between HIPEC and survival. Further investigation to define the role of HIPEC in the treatment of carcinomas of gastrointestinal primaries is warranted.
Spending on antineoplastic agents in the United States: 2011-2016.
Authors: Edward C. Li, Glen Schumock, Samuel Hong
Journal: Journal of Clinical Oncology (2017)

6618 Background: Novel antineoplastic therapies confer advantages in efficacy and safety over traditional cytotoxic agents, but they are costly. There is little information on recent trends in actual antineoplastic expenditures representative of the overall U.S. health care system or by healthcare sector. The objective of this study was to describe antineoplastic expenditures by year and healthcare sector in the U.S. Methods: Quintiles IMS National Sales Perspective data for the period of Jan 1, 2011, to Dec 31, 2016, were evaluated to describe antineoplastic agent expenditures. Actual expenditures were totaled by health care sector and calendar year, and then adjusted for U.S. medical-cost inflation (part of the overall consumer price index) to 2016 dollars. Growth was calculated as the percentage increase from previous years. Descriptive statistical analysis was used. Results: Total antineoplastic expenditures increased from $26.8 billion in 2011 to $38.9 billion in 2016. Compared to the previous year, spending increased by 13.7%, 15.6%, 13.4%, 6.3%, and 0.4% in 2016, 2015, 2014, 2013, and 2012, respectively. In hospitals and clinics, spending on biologics grew by 80% from 2011 to 2016. Rituximab, bevacizumab, and trastuzumab expenditures continue to be high ($3.7, $3.0, and $2.6 billion in 2016, respectively) while nivolumab spending increased from $765 million in 2015 to $2.6 billion in 2016. Cytotoxic drug spending remained flat during the study period due to the availability of multiple generic products. Large percentage decreases in spending were seen for oxaliplatin (-97%), docetaxel (-98%), gemcitabine (-92%), bendamustine (-56%) and decitabine (-94%) in 2016 compared to 2011. Conclusions: Antineoplastic expenditures increased significantly since 2011 and are expected to continue to do so with the anticipated approval of additional novel but costly cancer therapies, and because of an aging population. [Table: see text]
Phase III randomized trial of maintenance pegylated liposomal doxorubicin (PLD) / carboplatin versus without in patients with advanced ovarian cancer: An Asian Gynecologic Oncology Group study.
Authors: Chyong-Huey Lai, Elizabeth Vallikad, Hao Lin, Lan-Yan Yang, Yu-Che Ou, Hung-Hsueh Chou, Cheng-Tao Lin, Huei-Jean Huang, Kung-Gen Huang, Jentai Qiu, Yao-Ching Hung, Tzu-I Wu
Journal: Journal of Clinical Oncology (2018)

5584 Background: An Asian Gynecologic Oncology Group (AGOG) phase III randomized trial was conducted to determine whether maintenance chemotherapy after complete remission could improve progression-free survival (PFS) in FIGO stages III/IV ovarian cancer. Methods: Between June 2007 and September 2014, 45 patients were enrolled and randomized (1:1) with stratification factor of residual tumor and stage. One patient was found ineligible shortly after registration and randomization and was excluded without treatment. Twenty-three patients were randomized to arm A (4-weekly carboplatin AUC4 and liposomal doxorubicin 30 mg/m2) for six cycles and 21 patients were randomized to arm B (observation). The primary end-point was PFS. Overall survival (OS) was calculated as secondary end-point. Results: Enrollment was slow, therefore a decision of closing accrual was made by the AGOG Board meeting when 7+ years had lapsed. We ended the study after the last enrolled patient had completed 3-year follow-up. With a median follow-up of 80.1 months, 30 patients experienced cancer progression (14 [60.9%] for arm A and 16 [76.2%] for arm B). The median PFS was significantly better in arm A (38.9 months) than arm B (9.2 months) (log-rank p = 0.038), and the median OS was marginal better in arm A (not applicable, > 50 % of patients were alive at study end) than arm B (42.8 months) (log-rank p = 0.117). Overall rates of grade 3/4 adverse events were 60.9 % for arm A and 0.0 % for arm B (p < 0.001). Grade 3/4 including neutropenia were more frequent in arm A than arm B with 30.4% and 0.0%, respectively (p = 0.0094). Conclusions: Despite limitation in small sample size, it suggests that maintenance chemotherapy after complete remission could be beneficial significantly improving PFS in stages III/IV ovarian cancer. Clinical trial information: ACTRN12607000329460.