tbuckley/cabot-search huggingface dataset:
Surveillance imaging with FDG-PET/CT in the post-operative follow-up of stage 3 melanoma.
Authors: Louise Sayers, Jeremy Howard Lewin, Damien Kee, Imogen Walpole, Alexandra Sanelli, Alan Herschtal, John Spillane, David E. Gyorki, David Speakman, Vanessa Estall, Simon Donahoe, Miklos Pohl, Kathy Pope, Margaret Chua, Shahneen Kaur Sandhu, Grant A. McArthur, Christopher McCormack, Michael A. Henderson, Rodney J Hicks, Mark J. Shackleton
Journal: Journal of Clinical Oncology (2017)

9563 Background: With the evolving treatment landscape in metastatic melanoma, approaches to disease surveillance post resection in stage 3 disease requires reconsideration. We previously reported the outcomes of sub-stage-specific schedules of combined fluorodeoxyglucose-positron emission and computerized tomography (PET/CT) surveillance at high risk of relapse following surgery. The aim of this study was to provide an update on our surveillance protocol with an extended sample size and longer duration of follow-up. Methods: From 2009, patients with AJCC stage 3 melanoma underwent PET/CT scans according to pre-specified schedules based on Bayesian probabilities of sub-stage-specific relapse. Schedules were stage 3A: 6, 18 mo; stage 3B: 6, 12, 18, 24, 36, 48, 60 months; stage 3C: 6, 12, 18, 24, 36 months. Contingency tables were used to evaluate the sensitivity, specificity and predictive values of these schedules. Results: In total, 171 patients (3A: 34; 3B: 93; 3C:44) underwent 553 PET/CT scans with a median follow up of 47 months. Relapses were identified in 65 (38%) patients of which (72%) were asymptomatic at the time of radiologically documented relapse. False positive results occurred in 8%. The positive predictive value (PPV) of an individual scan for diagnosing true recurrence was 77% (64-87%). Negative scans at 6 months had negative predictive values (NPV) between 57% in Stage 3A to 69% in Stage 3B for relapse. Sensitivity and specificity of the overall approach of sub-stage-specific PET/CT surveillance for detecting disease relapse were 70% and 89%, respectively. Evaluable predictive values for detecting disease relapse were: stage 3A: PPV:56%, NPV:76%; 3B: PPV 83%, NPV 86%; stage 3C: PPV 84%, NPV 84%. 32 of 65 patients (49%; 3A: 1; 3B: 7; 3C: 2) underwent resection of relapsed disease and 10 of these patients remained free of disease with a median follow-up of 24 months. Conclusions: Sub-stage-specific PET/CT is effective in detecting asymptomatic recurrence in stage 3 melanoma, and is associated with a high rate of disease resection at relapse.
Oxidized Low-Density Lipoprotein Receptor in Lymphocytes Prevents Atherosclerosis and Predicts Subclinical Disease
Authors: Katerina Tsilingiri, Hortensia de la Fuente, Marta Relaño, Raquel Sánchez-Díaz, Cristina Rodríguez, Javier Crespo, Fátima Sánchez-Cabo, Ana Dopazo, José L. Alonso-Lebrero, Alicia Vara, Jesús Vázquez, José M. Casasnovas, Fernando Alfonso, Borja Ibáñez, Valentín Fuster, José Martínez-González, Pilar Martín, Francisco Sánchez-Madrid
Journal: Circulation (2019)

Although the role of Th17 and regulatory T cells in the progression of atherosclerosis has been highlighted in recent years, their molecular mediators remain elusive. We aimed to evaluate the association between the CD69 receptor, a regulator of Th17/regulatory T cell immunity, and atherosclerosis development in animal models and in patients with subclinical disease.Low-density lipoprotein receptor-deficient chimeric mice expressing or not expressing CD69 on either myeloid or lymphoid cells were subjected to a high fat diet. In vitro functional assays with human T cells were performed to decipher the mechanism of the observed phenotypes. Expression of CD69 and NR4A nuclear receptors was evaluated by reverse transcription-polymerase chain reaction in 305 male participants of the PESA study (Progression of Early Subclinical Atherosclerosis) with extensive (n=128) or focal (n=55) subclinical atherosclerosis and without disease (n=122).After a high fat diet, mice lacking CD69 on lymphoid cells developed large atheroma plaque along with an increased Th17/regulatory T cell ratio in blood. Oxidized low-density lipoprotein was shown to bind specifically and functionally to CD69 on human T lymphocytes, inhibiting the development of Th17 cells through the activation of NR4A nuclear receptors. Participants of the PESA study with evidence of subclinical atherosclerosis displayed a significant CD69 and NR4A1 mRNA downregulation in peripheral blood leukocytes compared with participants without disease. The expression of CD69 remained associated with the risk of subclinical atherosclerosis in an adjusted multivariable logistic regression model (odds ratio, 0.62; 95% CI, 0.40-0.94; P=0.006) after adjustment for traditional risk factors, the expression of NR4A1, the level of oxidized low-density lipoprotein, and the counts of different leucocyte subsets.CD69 depletion from the lymphoid compartment promotes a Th17/regulatory T cell imbalance and exacerbates the development of atherosclerosis. CD69 binding to oxidized low-density lipoprotein on T cells induces the expression of anti-inflammatory transcription factors. Data from a cohort of the PESA study with subclinical atherosclerosis indicate that CD69 expression in PBLs inversely correlates with the presence of disease. The expression of CD69 remained an independent predictor of subclinical atherosclerosis after adjustment for traditional risk factors.
Immunotherapy in advanced cancers and predictor factors for outcome: An Indian experience.
Authors: Kushal Gupta, Vanita Noronha, Amit Joshi, Vijay Patil, Sangeetha Parthiban, Rajesh Bollam, Sujay Srinivas, Dilip Vallathol, Abhishek Mahajan, Amit Janu, Kumar Prabhash
Journal: Journal of Clinical Oncology (2018)

e15065 Background: Worldover, lung, urothelial & head-neck cancers constitute 13%, 5.5% & 3.7% of all cancers, comprising 19.4%, 3.7% & 3.6% of all cancer deaths, respectively. In India, incidence of lung cancer, urothelial cancers, & head-neck cancers is 6.9% , 2.6% & 11.8% respectively. Mortality of lung, urothelial & head-neck cancers was 9.3%, 2.3% & 12.8% respectively, translating to 0.16 million yearly deaths. With high recurrence rates, response to second line therapies is poor. Immunotherapies targeting PD-L1 and CTLA-4, have been approved for use in advanced lung, head-neck & urothelial cancers post-platinum therapy. We analysed results (response & toxicities) of 62 patients, undergoing immunotherapy at our centre. Methods: Cohort of 62 patients (51 males,11 females) had median age 54 years (23-70) .ECOG-PS varied 0-3. 50 patients had ≥2 lines of therapy &12 patients had 1 line. Total 32 lung cancer patients (Nivolumab = 29, Pembrolizumab+ChT = 3), 20 patients of head-neck cancer (Nivolumab = 20) & 10 patients of urothelial / renal cancers (Nivolumab = 9,Pembrolizumab = 1). Nivolumab dose was 3mg/kg q2weekly. Pembrolizumab dose was 200 mg q3weekly.All 62 patients received at least 1 dose of immunotherapy, with maximum of 30 cycles in 1 patient. Average number of doses in all patients was 5. Toxicity was assessed (CTCAE 4.1) in all 62 patients at every visit. Response evaluation was done in 49 patients clinically and using CT scan (RECIST 1.1) every 4 to 6 cycles. Average number of cycles received in these 49 patients was 5.5 Results: Response was assessed in 49 patients. Best response averaged at 4 cycles with 0% complete responders, 22.4% (11 patients) partial response, 34.6%(17 patients) stable disease & 42.8% (21 patients) progressive disease. Toxicity assessed in 62 patients who received at least 1 cycle. Commonest toxicities were fatigue (16.6 %; Gr2-6, Gr3-4), hyponatremia (13%; Gr2-1, Gr3-7), transaminitis (3%; Gr3-2) & anemia (8.3%; Gr2- 3, Gr3- 2), significant proteinuria (3%; Gr2-1,Gr3-1), & severe pneumonitis (3%; Gr3-2). One patient had acute coronary event after cycle 10 Conclusions: Immunotherapy is feasible option for treating advanced lung, head-neck and urothelial/renal cancers with acceptable toxicities.
A pilot study of immune checkpoint inhibition in combination with radiation therapy in patients with metastatic pancreatic cancer.
Authors: Austin G. Duffy, Oxana V. Makarova-Rusher, David E Kleiner, Christine Alewine, William Douglas Figg, Seth M. Steinberg, Elliot B Levy, Venkatesh P Krishnasamy, Bradford J. Wood, Deborah E. Citrin, Jennifer C Jones, Tim F. Greten
Journal: Journal of Clinical Oncology (2017)

e15786 Background: Durvalumab is a human IgG1 monoclonal antibody directed against PD-L1. Tremelimumab is a selective human IgG2 monoclonal antibody against CTLA-4. Several studies have documented an increase in peripheral antitumor immunity following radiation. The hypothesis of this study is that the effect of immune checkpoint inhibition (ICI) can be enhanced by radiation in pancreatic adenocarcinoma (PAC). Methods: Patients with histologically confirmed metastatic PC with primary in-situ or metastatic SBRT-amenable disease are being enrolled to this pilot study. Primary objective to determine safety, tolerability and feasibility of immune checkpoint inhibition [comprising either Durvalumab alone (Cohort A), or combined durvalumab and tremelimumab (Cohort B)] in combination with stereotactic body radiation therapy (SBRT) at two different schedules (8Gy/single fraction or 25Gy in 5 fractions). Select eligibility criteria are as follows: at least 1 measurable metastatic lesion by RECIST 1.1 accessible for biopsy. No limit to the number of prior chemotherapy regimens; ECOG ≤ 1; Life expectancy of greater than 3 months. Acceptable organ and bone marrow function. No active autoimmune disorders. Results: N = 24 patients with chemorefractory metastatic PC have so far been enrolled; M/F = 13/11; Median age = 61. Treatment was well tolerated. No DLT encountered. The most common toxicity was fatigue (G1/2) in all patients in DL2. 5/24 pts had early discontinuation ( &lt; 4 wks) due to rapid PD. No objective responses have been seen. 5 pts (21%) had SD as best response. Conclusions: Immune checkpoint inhibition in combination with SBRT in advanced pancreatic cancer is safe and feasible. Preliminarily no objective responses have been seen for these schedules of SBRT with durvalumab. The study is continuing with evaluation of SBRT with dual checkpoint inhibition (durvalumab and tremelimumab). Clinical trial information: NCT02311361.
Neutrophil-to-lymphocyte ratio as a potential prognostic factor of disease-free survival in high-risk renal cell carcinoma: Analysis of the S-TRAC trial.
Authors: Anup Patel, Alain Ravaud, Robert J. Motzer, Allan J. Pantuck, Michael D. Staehler, Bernard Escudier, Jean-Francois Martini, Sriram Krishnaswami, Michelle Casey, Mariajose Lechuga, Xun Lin, Daniel J. George
Journal: Journal of Clinical Oncology (2018)

4562 Background: Sunitinib significantly improved disease-free survival (DFS) vs placebo (PBO) in patients (pts) with loco-regional renal cell carcinoma (RCC) at high risk of recurrence post nephrectomy. Neutrophil-to-lymphocyte ratio (NLR) is a marker of systemic inflammatory response. A post hoc exploratory analysis of the S-TRAC trial evaluated NLR as a potential prognostic factor in the RCC adjuvant setting. Methods: Sunitinib- and PBO-treated pts from S-TRAC were categorized into baseline (BL) NLR < 3 and ≥3 subgroups to explore the association between BL NLR (post nephrectomy) and DFS. Subgroups were based on low NLR ( < 3) being associated with long-term response in metastatic RCC. Associations between DFS and change in NLR from BL at Wk 4 were explored. Kaplan–Meier estimates were provided and Cox proportional analysis was performed. Results: In all, 605 pts from S-TRAC with BL NLR values were analyzed: 465 with NLR < 3 and 140 with NLR ≥3. At BL, significant differences between NLR < 3 vs ≥3 subgroups were seen for age (median 56.0 vs 60.0 y; P= .0161) and race (white [81.9% vs 90.0%], black [0.6% vs 0.7%], asian [14.6% vs 5.7%], other [2.8% vs 3.6%]; P= .0226). NLR < 3 vs ≥3 was statistically significant in the univariate analyses of DFS (hazard ratio [HR] 1.39; P= .0418); median 5.84 y (NLR < 3) vs not reached (NLR ≥3). A lower BL NLR was associated with shorter DFS. NLR < 3 vs ≥3 was also statistically significant in a multivariate analysis of DFS (HR 2.29; P= .0348). More pts treated with sunitinib (73%) had ≥25% decrease in NLR at Wk 4 vs PBO (20%). A ≥25% decrease in Wk 4 NLR showed a trend towards longer DFS vs no NLR change (HR 0.744; P= .0729), while a ≥25% increase in NLR at Wk 4 showed a trend towards shorter DFS vs no change (HR 1.112; P= .6771). NLR change from BL at Wk 4 was associated with treatment (sunitinib vs PBO; P< .0001). Conclusions: In S-TRAC, lower BL NLR might be a prognostic factor of shorter DFS. A ≥25% decrease in Wk 4 NLR showed a trend towards prolonged DFS. Additional data on CD8, neutrophils and lymphocytes will be presented. Clinical trial information: NCT00375674.
Abstract 15520: Use of the Novel Biomarker-Based ABC-Bleeding Risk Score Over Time in Atrial Fibrillation: Insights From the ARISTOTLE Trial
Authors: Ziad Hijazi, Jonas Oldgren, Johan Lindbäck, John H Alexander, Michael Hanna, Elaine M Hylek, Renato D Lopes, Christopher B Granger, Agneta Siegbahn, Lars Wallentin
Journal: Circulation (2016)

Introduction: A novel biomarker-based risk score for major bleeding during oral anticoagulation was recently developed to improve outcomes in patients with atrial fibrillation (AF). This ABC-bleeding score (Age, Biomarkers [GDF-15, hemoglobin (Hb), and cardiac troponin (cTnT)], and Clinical history of prior bleeding) performed better than the HAS-BLED in both the internal (n=14,537) and the external validation cohorts (n= 8,468). We now evaluated the performance of the ABC-bleeding score over time by re-analyzing biomarkers after two months. Methods: The ARISTOTLE trial compared apixaban vs warfarin in AF patients followed for a median of 1.8 years. Safety endpoint was ISTH major bleeding. In the biomarker substudy, 4,780 patients provided plasma samples both at entry and after 2 months. GDF-15 and cTnT were measured with Immunoassays. Hb measurements were performed at 3 month within the main trial. C indices and calibration plots were used to evaluate the score at baseline and at 2 months. Results: Chang...
Distribution and pathogenicity of nsSNPs in receptor tyrosine kinases (RTKs) in patients with colorectal cancer.
Authors: Matthew K Stein, Saradasri Karri, Lindsay Kaye Morris, Srishti Sareen, Kruti Patel, Ray Scott Daugherty, David Shibata, Ari M. Vanderwalde, Lee Steven Schwartzberg, Michael Gary Martin
Journal: Journal of Clinical Oncology (2017)

e15012 Background: Non-synonymous single nucleotide polymorphisms (nsSNPs) occur along the entire sequence of RTKs and can promote oncogenic activity. As prior “hot-spot” testing was limited to the tyrosine kinase domain (TKD), next-generation sequencing (NGS) allows the discovery of novel extra-TKD variants. Methods: We analyzed all nsSNPs in 29 RTKs of colon cancer patients (pts) who received tumor profiling (2013-2015) with Caris NGS. Mutations were classified by location including the TKD, extracellular domain (ECD), transmembrane domain (TM), juxtamembrane domain (JM) and carboxy-terminal (CT) regions. nsSNPs underwent in silico analysis using PolyPhen-2 (Harvard) to predict if damaging (pnsSNP). Results: 110 pts were identified with a median age of 58 years (range 37-86); 55% male; 57% white, 41% black. 51 were KRAS+, 12 BRAF+, 5 NRAS+ and 5 were microsatellite unstable (MSI-H); 67 were left-sided, 31 right-sided, 10 transverse and 2 unknown. A total of 171 nsSNPs and 7 pathogenic mutations (Pmut) were detected: ERBB2 (ECD S310F, TKD V777L and TKD V842I), ERBB3 (ECD A232V and TKD Q809R), FGFR2 (ECD S252L) and RET (TKD L790F). 83/110 (76%) pts had ≥1 RTK mutation (median 1; range 0-9). 72/171 (42%) variants were pnsSNPs and found in 50 (45%) pts; 14% of pts had ≥2. All 29 RTKs had nsSNPs with median 6 (range 2-12); 24/29 RTKs had a Pmut or pnsSNP (median 2; range 0-8). RTKs with the most nsSNPs were EPHA5 (8/10 were pnsSNPs), PDGFA (7/8), ALK (6/8), ERBB4 (5/8), NTRK3 (5/6), cKIT (4/9), ROS1 (3/12), PDGFRB (3/6) and FGFR1 (3/6). nsSNPs were distributed across all RTK domains: 50% were ECD (30/86 pnsSNPs), 27% TKD (28/46), 13% CT (7/22), 5% JM (6/9) and 5% TM (1/8). No significant difference was seen between pnsSNP incidence and sidedness or KRAS/BRAF/NRAS status. In MSI-H pts, 13/22 variants were pnsSNPs (median 2; 1-5); 4/5 MSI-H were right-sided (Fisher’s exact p &lt; 0.01). Conclusions: &gt; 70% colon cancer pts had ≥1 mutation in 29 RTKs with &gt; 70% outside the TKD, and &gt; 40% pnsSNPs. MSI-H had a higher incidence of pnsSNPs; further study is warranted to determine their significance and actionability.
FORWARD I (GOG 3011): A randomized phase 3 study to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer (EOC), primary peritoneal cancer, or primary fallopian tube cancer.
Authors: Kathleen N. Moore, Ignace Vergote, Ana Oaknin, Nicoletta Colombo, Susana N. Banerjee, Amit M. Oza, Patricia Pautier, Catherine Margaret Kelly, Karim S. Malek, Rodrigo Ruiz-Soto, Michael J. Birrer
Journal: Journal of Clinical Oncology (2017)

TPS5607 Background: Elevated FRα expression is characteristic of a number of solid tumors, including EOC, thereby providing an attractive candidate for targeted therapeutic approaches. Mirvetuximab soravtansine is an antibody-drug conjugate (ADC), comprising a FRα-binding antibody linked to the tubulin-disrupting maytansinoid DM4, that has shown single agent clinical activity and a favorable safety profile in an ongoing, first-in-human phase 1 trial (NCT01609556). Methods: FORWARD I is a randomized phase 3 study designed to evaluate the efficacy of mirvetuximab soravtansine compared with that of standard-of-care chemotherapy in adult patients with platinum-resistant EOC, primary peritoneal cancer, or fallopian tube cancer. Confirmation of FRα positivity by immunohistochemistry (medium or high expression; ≥ 50% of cells with at least moderate staining intensity) and ≤ 3 prior lines of therapy are required for inclusion. A maximum of 333 patients are expected to be recruited. Patients will be randomized 2:1 to Arm 1 (intravenous mirvetuximab soravtansine at a dose of 6.0 mg/kg, calculated using adjusted ideal body weight, on Day 1 of a 21-day cycle) or Arm 2 (investigators’ choice chemotherapy: paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary efficacy endpoint is progression-free survival (PFS; by blinded independent central review) and secondary endpoints include objective response rate, quality of life, overall survival, safety and tolerability, and duration of response. The first patient was enrolled in January 2017. Clinical trial information: NCT02631876.
Liver-directed treatment for patients with uveal melanoma hepatic metastasis: A retrospective analysis of overall survival.
Authors: Rino S Seedor, David J. Eschelman, Carin F. Gonsalves, Robert D. Adamo, Marlana M. Orloff, Anjum Amjad, Erin Sharpe-Mills, Ryan Michael Weight, Allison Gradone, Carol L Shields, Jerry A Shields, Michael J. Mastrangelo, Takami Sato
Journal: Journal of Clinical Oncology (2018)

9592 Background: Despite successful treatment of primary uveal melanomas, up to 50% of patients subsequently develop systemic metastasis, with the liver involved in up to 90% of patients. At our institution, recognition of the poor prognosis associated with liver metastasis has led to the use of various liver-directed treatment modalities including transarterial chemoembolization (TACE) with BCNU, drug-eluting beads with doxorubicin (DEBDOX), immunoembolization (IE) with GM-CSF, and radioembolization with Yttrium 90 radioactive microspheres. The purpose of this study is to compare overall survival between uveal melanoma patients with hepatic metastasis before and after the shift of initial treatment from systemic to liver-directed approaches. Methods: A retrospective single-institution chart review was performed on consecutive series of uveal melanoma patients with hepatic metastasis who were treated at Thomas Jefferson University between 1971–1993 (Cohort 1, n = 98) and 2000–2017 (Cohort 2, n = 634). The following data was collected from medical records: primary tumor stage and genetic abnormalities, primary eye treatment, date to hepatic and extra-hepatic metastasis, types of liver-directed and systemic treatments utilized, and date of death. Time from development of hepatic metastasis to death (OS-Liver) and time from initial treatment of primary uveal melanoma to death (OS-Eye) in individual cohorts were measured and analyzed. Results: 81% of cohort 1 patients received systemic chemotherapy as their initial treatment for liver metastasis, while 91% of cohort 2 patients (n = 574) initially received liver-directed treatments including IE (n = 296), BCNU TACE (n = 147), DEBDOX (n = 45), radioembolization (n = 37), and other liver-directed treatments (n = 49). OS-Liver in cohort 1 and cohort 2 was 4.8 months and 16.4 months, respectively (P < 0.001). More importantly, OS-Eye in cohort 2 (5.1 years) is much longer than that of cohort 1 (3.3 years) (P < 0.001). Conclusions: Liver-directed treatments provided significant survival benefit for uveal melanoma patients with hepatic metastasis.
The Spruce clinical trial: Double-blind randomized phase II trial of carboplatin and pemetrexed +/- apatorsen in patients with previously untreated stage IV non-squamous non-small-cell lung cancer.
Authors: Dianna Shipley, David Michael Waterhouse, Suzanne Fields Jones, Dawn Michelle Stults, Patrick J. Ward, Kent C. Shih, Michael Brian Hemphill, Michael McCleod, Robert C. Whorf, Ray D. Page, Joesph Stilwell, Tarek Mekhail, Kirsten Anderson, Cindy Jacobs, John D. Hainsworth, David R. Spigel
Journal: Journal of Clinical Oncology (2016)

9092 Background: Hsp27 is over-expressed in many cancers and is associated with inhibition of chemotherapy-induced apoptosis. Apatorsen (A) is an antisense oligonucleotide that binds to Hsp27 mRNA and inhibits Hsp27 production; A has been shown to inhibit tumor growth and sensitize tumor cells to chemotherapy in numerous malignancies, including lung. Preclinical models demonstrate increased apoptosis with pemetrexed and platinum with A treatment. This study assessed the benefit of adding A to standard 1st line chemotherapy for patients (pts) with advanced non-squamous non-small-cell lung cancer (NS-NSCLC). The primary endpoint was progression-free survival (PFS), with overall survival to be assessed later as a secondary endpoint. Methods: 155 pts with advanced NS-NSCLC were randomized 1:1, stratified by histology and smoking status. Pts received 3 IV loading doses of 600 mg A or placebo (PL) one week (wk) prior to chemotherapy. Pts received pemetrexed 500 mg/m2, carboplatin AUC 6, and 600 mg A or PL on Day 1 every 3 wks. A or PL was also administered on days 8 and 15 of each cycle. Results: 155 pts were randomized. Demographics were similar between arms: median age 66 yr vs 67 yr; males 49% vs 49%; current/former smokers 70% vs 64% for A vs PL, respectively. Median PFS was A 6.0 months (mo) vs PL 4.9 mo; HR (2-sided 95% CI) was 0.922 (0.634, 1.340), p = 0.6687. Objective response rate: A 26% vs PL 31%. Median duration of treatment was A 15 wks vs PL 19 wks. High baseline serum Hsp27 levels ( > 9.3 ng/mL) were observed in 10% of pts. For pts with high Hsp27, median PFS was A 10.8 mo vs PL 4.8 mo. Grade 3/4 treatment-related toxicities were A thrombocytopenia (28%), neutropenia (27%), anemia (18%), leukopenia (12%), vs PL thrombocytopenia (30%), neutropenia (31%), anemia (20%), leukopenia (24%). Conclusions: A was not associated with a statistically significant improvement in PFS when added to 1st line NS-NSCLC chemotherapy. Subset data suggest that high Hsp27 expression may be a method for optimally selecting pts for tx. OS data are pending and expected later this year. Clinical trial information: NCT01829113.