bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and safety of nivolumab in patients with metastatic renal cell carcinoma (mRCC) and brain metastases: Preliminary results from the GETUG-AFU 26 (Nivoren) study.
Authors: Escudier Bernard J. , Chabaud Sylvie , Borchiellini Delphine , Gravis Gwenaelle , Chevreau Christine , Brachet Pierre Emmanuel , Geoffrois Lionnel , Laguerre Brigitte , Mahammedi Hakim , Negrier Sylvie , Rolland Frederic , Gross Goupil Marine , Habibian Muriel , Albiges Laurence 
Published: September 2018

4563 Background: Nivolumab (N) has been shown active in patients (pts) with mRCC after failure of 1 or 2 TKIs. Efficacy and safety of N in pts with brain metastases (BM) from RCC is still unknown. The aim of this study is to report preliminary data of the Nivoren study in pts with BM. Methods: GETUG-AFU 26 (Nivoren) is a prospective phase 2 study assessing safety and efficacy of N in a broader mRCC patient population than those recruited in the pivotal phase 3, including pts with BM (previously treated or not, but not requiring steroids), with previous mTOR inhibitor, with PS 2 as well as in previously highly pretreated pts. N was given every 2 weeks at 3mg/kg, until disease progression or unacceptable toxicity. Treatment was allowed beyond progression in case of clinical benefit. All pts had brain CT scan or MRI at baseline. Results: Up to December 2016 , 588 pts have been enrolled including 55 pts with BM (35 (67%) ,6 (12%) and 11 (21%) with 1, 2 or > 2 BM, respectively. Of those 55 pts, 10 pts (23%) were PS 2 and 25 (58%) PS 1, and 16 patients (29%) had received more that 2 lines of therapy. No previous treatment for BM was performed in 67% (n = 37), while 9% had previous brain surgery (n = 5 ;) or brain radiation (n = 17 (31%). 2/55 pts never received N. Median duration of therapy in BM pts was 2.4 months (varying from 0 to 9) with a 3-months PFS of 60% (IC95% = 45 – 73). Median OS is not reached at the time of this analysis. Among 44 pts with assessment of response on BM, 10 (23%) had objective response while 21 (48%) had local progressive disease. Neurologic deterioration requiring steroids was observed in 15 pts (32%) . Updated data will be presented at the meeting. Conclusions: This is the first large study to report preliminary safety and efficacy of N in RCC pts with BM. Safety of N in this pt population appears to be acceptable, although some pts do require steroids because of brain progressive disease. Objective response in the brain was observed in 23% of pts. Further follow up is required to determine the real benefit of N in this group of mRCC pts. Clinical trial information: NCT03013335.
Sunitinib in patients with metastatic renal cell carcinoma: Clinical outcome according to IMDC risk group.
Authors: Rini Brian I. , Hutson Thomas E. , Figlin Robert A. , Lechuga Mariajose , Valota Olga , Serfass Lucile , Casey Michelle , Motzer Robert J. 
Published: September 2018

4584 Background: In a phase III study (NCT00083889), treatment-naïve patients (pts) with metastatic renal cell carcinoma (mRCC) of all prognostic risk groups were treated with sunitinib or interferon-α (IFN-α). Since sunitinib has become the reference standard of care and serves as the comparator in multiple randomized trials sometimes restricted to prespecified risk groups, a retrospective analysis of outcome according to prognostic group from the phase III study was performed. Methods: Investigator-assessed efficacy data were analyzed for pts based on risk group (International mRCC Database Consortium [IMDC] criteria). The objective was to determine objective response rate (ORR), median progression-free survival (mPFS), and median overall survival (mOS) benchmarks by risk group. Results: Of sunitinib-treated pts, 134 were favorable, 205 were intermediate, and 34 were poor risk. The median sunitinib treatment duration/median number of cycles was 16.7 mo/12 cycles, 11.0 mo/8 cycles and 2.6 mo/2.0 cycles for favorable-, intermediate-, and poor-risk pts, respectively. ORR, PFS, and OS benchmarks for sunitinib-treated pts are shown in the Table. In sunitinib-treated intermediate-risk pts with 1 vs 2 risk factors, respectively: ORR was 43.3% vs 40.8%, mPFS (95% confidence interval [95% CI]) was 11.2 (9.7–13.6) vs 8.5 (5.6–10.7) mo, and mOS (95% CI) was 28.2 (23.0–not estimable) vs 16.3 (13.2–19.4) mo. Conclusions: This retrospective analysis provides ORR, PFS, and OS benchmarks for current and future clinical trial interpretation in mRCC pts with different prognostic risk treated with sunitinib. [Table: see text]
A phase IV, randomized, double-blind, placebo (PBO)-controlled study of continued enzalutamide (ENZA) post prostate-specific antigen (PSA) progression in men with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC).
Authors: Attard Gerhardt , Borre Michael , Gurney Howard , Loriot Yohann , Andresen Corina , Kalleda Ranjith , Pham Trinh , Taplin Mary-Ellen 
Published: September 2018

5004 Background: We hypothesized resistance to the androgen receptor inhibitor ENZA is due to increases in androgens and can be overcome by combination with the androgen synthesis inhibitor abiraterone (abi). The phase 4 PLATO trial (NCT01995513) is evaluating the safety and efficacy of continued ENZA + abi/prednisone (abi/P) vs PBO + abi/P after PSA progression on ENZA. Methods: In Period (P) 1, men with chemotherapy-naïve mCRPC received ENZA (160 mg); men with no PSA increase from baseline at wk 13 and 21 continued treatment until PSA progression (≥ 25% increase and ≥ 2 ng/mL above nadir). Eligible men were then randomized 1:1 in P2 to ENZA + abi/P (1000 mg/10 mg) or PBO + abi/P. The primary endpoint (EP) was progression-free survival (PFS; radiographic or unequivocal clinical progression, or death on study) in P2, with a prespecified sensitivity analysis of radiographic PFS (rPFS); protected secondary EPs were time to PSA progression (TTPP) and PSA response ≥ 50% in P2. Results: 509 men enrolled in P1. At data cutoff (Oct 7, 2016), 84 were active, 174 discontinued, and 251 were randomized in P2 (ENZA + abi/P, n = 126; PBO + abi/P, n = 125). Median treatment duration in P2 was 5.6 mo for both arms. PFS event by radiographic/clinical/death was 38%/25%/2% for ENZA + abi/P and 55%/18%/1% for PBO + abi/P. Median PFS was 5.7 mo for ENZA + abi/P and 5.6 mo for PBO + abi/P (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.61, 1.12; P = 0.22). Median TTPP was 2.8 mo for both arms (HR, 0.87; 95% CI, 0.62, 1.24; P = 0.45). PSA response rate was 0.8% for ENZA + abi/P and 2.5% for PBO + abi/P ( P = 0.31). Median rPFS was 10.0 mo for ENZA + abi/P and 7.0 mo for PBO + abi/P (HR, 0.67; 95% CI, 0.47, 0.94; P = 0.02). The most common (≥ 15%) adverse events for ENZA + abi/P vs PBO + abi/P were back pain (21% vs 23%), hypertension (20% vs 7%), nausea (17% vs 9%), and fatigue (14% vs 15%). Conclusions: ENZA + abi/P post PSA progression on ENZA was associated with increased hypertension and nausea and did not result in a statistically significant improvement in composite PFS. The signal seen in rPFS needs further evaluation. Clinical trial information: NCT01995513.
Duration of androgen deprivation therapy in high risk prostate cancer: Final results of a randomized phase III trial.
Authors: Nabid Abdenour , Garant Marie-Pierre , Martin André-Guy , Bahary Jean-Paul , Lemaire Celine , Vass Sylvie , Bahoric Boris , Archambault Robert , Vincent Francois , Bettahar Redouane , Carrier Nathalie , Duclos Marie , Souhami Luis 
Published: September 2018

5008 Background: Long-term androgen deprivation therapy (ADT) combined with radiotherapy (RT) is a standard treatment for patients with high-risk prostate cancer (HRPC). However, the optimal duration of ADT is not yet defined. The aim of this randomized trial (Clinical Trials.gov, #NCT00223171) was to compare outcomes of RT combined with either 36 or 18 months of ADT. Methods: Patients with HRPC were randomized to pelvic and prostate RT combined with 36 (arm 1) or 18 months (arm 2) of ADT. Overall survival (OS) and quality of life (QoL) were primary end points. OS rates were compared with Cox Regression model and QoL data were analyzed through mixed linear model. Results: 630 patients were randomized, 310 to arm 1 and 320 to arm 2. With a median follow-up of 9.4 years, 290 patients had died (147 arm 1 vs. 143 arm 2). The 10-year OS rate was 62.4% (95% confidence interval [CI] 56.4%, 67.8%) for arm 1 and 62.0% (95% CI 56.1%, 67.3%) for arm 2 (p = 0.8412) with a global hazard ratio (HR) of 1.024 (95% CI 0.813-1.289, p = 0.8411). QoL analysis showed a significant difference (p < 0.001) in 6 scales and 13 items favoring 18 months ADT with two of them presenting a clinically relevant difference in mean scores of ≥10 points. Conclusions: In HRPC, ADT combined with RT can be safely reduced from 36 to 18 months without compromising outcomes or QoL. 18 months of ADT represents a new standard of care in HRPC. Funded by AstraZeneca Pharmaceuticals Clinical trial information: NCT00223171.
9 weeks vs 1 year adjuvant trastuzumab in combination with chemotherapy: Results of the phase III multicentric Italian study Short-HER.
Authors: Conte Pier Franco , Bisagni Giancarlo , Frassoldati Antonio , Brandes Alba Ariela , Anselmi Elisa , Giotta Francesco , Aieta Michele , Gebbia Vittorio , Musolino Antonino , Garrone Ornella , Taverniti Cristiana , Cavazzini Giovanna , Turletti Anna , Rubino Daniela , Picardo Elisa , Ferro Antonella , Piacentini Federico , Balduzzi Sara , D'Amico Roberto , Guarneri Valentina 
Published: September 2018

501 Background: 1-year trastuzumab with chemotherapy is the standard adjuvant treatment for HER2+ breast cancer patients (pts). The efficacy of less extended trastuzumab exposure is still under investigation. The Short-HER study is an independent, non-profit study aimed to test the non-inferiority of 9 weeks vs 1 year of adjuvant trastuzumab. Methods: This is a phase III, multicenter, Italian trial where pts with HER2+ breast cancer were randomly assigned to: Arm A (Long) AC or ECx4 followed by 4 courses of 3-weekly docetaxel in combination with trastuzumab, followed by 14 additional courses of 3-weekly trastuzumab; or Arm B (Short) 3 courses of 3-weekly docetaxel plus weekly trastuzumab for 9 doses followed by FEC x3. When indicated, radiation therapy was administered after the completion of chemotherapy. Hormonal therapy started at the completion of chemotherapy for pts with hormone receptor positive tumors. This is a non-inferiority trial with disease-free survival (DFS) as primary end-point.Overall survival (OS) is evaluated as second primary analysis outcome. The sample size of 1250 pts has been estimated based on a hazard ratio <1.29 for the short arm to be non-inferior. The definitive analysis will take place after 198 DFS events. Secondary aims include 2-yrs failure rate, cardiac toxicity, correlative biomarkers analyses. Hazard ratio for DFS and OS (90% CI) will be estimated according to the Cox model. Data will also be analyzed by the Bayesian approach. Results: from Dec-2007 to Oct-2013, 1254 pts from 82 centers have been randomized. Pts characteristics are the following: median age 55 yrs (25-78), stage I 37.3%, IIA 40%, IIB 20.6%, III 2.1%. 30% of the pts had 1-3 positive nodes, 16% >=4. Sixty-eight% of the pts had ER+ tumors. Characteristics were balanced between the two arms. At the time of this writing, 95% of the planned DFS events have been reported. 105 Grade ≥2 cardiac events have been reported, 78 in arm A (long) and 27 in arm B (short). Grade 3-4 cardiac events were 20 in arm A and 11 in arm B. Conclusions: Shorter trastuzumab administration almost halves the rate of severe cardiac toxicity. Final DFS data will be available at the time of the meeting. Clinical trial information: NCT00629278.
Combination of PDL-1 and PARP inhibition in an unselected population with metastatic castrate-resistant prostate cancer (mCRPC).
Authors: Karzai Fatima , Madan Ravi Amrit , Owens Helen , Hankin Amy , Couvillon Anna , Cordes Lisa M , Fakhrejahani Farhad , Houston Nicole D. , Trepel Jane B. , Chen Clara , Edelman Daniel C. , Meltzer Paul S. , Steinberg Seth M. , Gulley James L. , Dahut William L. , Lee Jung-min 
Published: September 2018

5026 Background: About 30% of sporadic mCRPC has defects in DNA repair pathways which may confer sensitivity to PARP inhibition. There is limited data about PDL1 inhibition in mCRPC. We hypothesize increased DNA damage by olaparib (O) will complement anti-tumor activity of immune checkpoint blocking antibody, durvalumab (D), in mCRPC:NCT02484404. Methods: Single arm pilot study with accrual of 25 patients (pts) with mCRPC and biopsiable disease. Prior treatment with enzalutamide and/or abiraterone is required. D is given at 1500 mg iv q28 days + O 300 mg po q12 h. Primary endpoint is PFS. Pretreatment and on-study core biopsies undergo mutational analysis. Results: 10 pts have enrolled (median age 65 yr [range 51-79], median baseline PSA: 85.78 [22.17-809.9 ng/mL]). 7 pts have GS ≥ 8. Grade 3/4 adverse events include anemia 2/7 (29%), thrombocytopenia, lymphopenia, neutropenia, nausea, fatigue, UTI, and lung infection [1/7 each, (14%)]. 5/7 pts (71%) on-study >2 months (mos) have PSA declines > 50%. Median PFS is 7.8 mos (95% CI: 1.8 mos-undefined). Conclusions: Preliminary data shows D+O is well tolerated with activity in an unselected population. Accrual is ongoing with biomarker analysis. Clinical trial information: NCT02484404. [Table: see text]
Efficacy of cabazitaxel (CABA) rechallenge in heavily-treated patients with metastatic castration-resistant prostate cancer (mCRPC).
Authors: Thibault Constance , Eymard Jean-Christophe , Hardy-Bessard Anne-Claire , Birtle Alison J. , Krainer Michael , Baciarello Giulia , Flechon Aude , Le Moulec Sylvestre , Spaeth Dominique , Laguerre Brigitte , Caffo Orazio , Deville Jean-Laurent , Beuzeboc Philippe , Hasbini Ali , Gross-Goupil Marine , Helissey Carole , Bennamoun Mostefa , Oudard Stephane 
Published: September 2018

5033 Background: Only 2 chemotherapies have shown an overall survival (OS) benefit in mCRPC: docetaxel (DOC) and CABA. In patients (pts) previously treated with a new hormonal therapy (NHT: enzalutamide or abiraterone), DOC and CABA, therapeutic options are limited. We previously reported some activity of DOC rechallenge in good responders to first-line DOC. We present here the results of a retrospective study evaluating the efficacy and safety of CABA rechallenge. Methods: Records of 70 mCRPC pts rechallenged with CABA were collected in 17 centers (France, Italy, UK, Austria). To be included, pts should have previously received DOC, NHT and CABA with a good response to CABA. Results: Of these 70 pts, 52 received DOC-NHT-CABA, 15 DOC-CABA-NHT and 3 NHT-DOC-CABA. At rechallenge, 83% had a high-volume disease (CHAARTED definition), 10% had visceral mets, 66% consumed narcotic analgesics, 68 % were ECOG 0-1 and median neutrophil/lymphocyte ratio (NLR) was 3.1. CABA was rechallenged for a median of 6 cycles (25 mg/m2 q3w, 59%; 20 mg/m2, 27%; 16 mg/m2q3w 11%) with prophylactic G-CSF in 47%. Median time from last CABA cycle was 8.6 months (mo). CABA rechallenge had an acceptable tolerability: 7 pts (10%) had grade 3-4 toxicity (neutropenia). Data on efficacy are reported in Table 1. Median progression-free survival (PFS) was 11.3 mo with DOC, 12 mo with NHT, 11.9 mo with first CABA (median 8 cycles), and 7.8 mo with CABA rechallenge. Median OS calculated from the first life-extending therapy was 59.9 mo (95% CI 47.8; 66.4). Conclusions: This retrospective cohort of heavily treated mCRPC pts suggests that CABA rechallenge has a good activity with a manageable toxicity. CABA rechallenge might be an option in heavily treated pts still fit to receive chemotherapy. [Table: see text]
Linking tumor mutational load to clinical responses to ipilimumab (IPI) in men with advanced prostate cancer (PCa).
Authors: Subudhi Sumit Kumar , Aparicio Ana , Troncoso Patricia , Zhang Jianhua , Gumbs Curtis , Wu Chang-jiun , Gao Jianjun , Vence Luis M , Blando Jorge M , Corn Paul Gettys , Araujo John C. , Zurita Amado J. , Prokhorova Ina N. , Van Alstine Michael , Logothetis Christopher , Futreal Andrew , Allison James Patrick , Sharma Padmanee 
Published: September 2018

5065 Background: Tumor mutational load and neoantigens have been associated with responses to immune checkpoint therapies in patients (pts) with melanoma and lung cancer. We designed a clinical trial (NCT02113657) in advanced PCa to determine whether the induction of antitumor responses by IPI correlate with T cell responses to PCa neoantigens. Methods: All advanced PCa pts enrolled into this study had sufficient DNA/RNA from tumor tissue obtained prior to receiving IPI (3 mg/kg every 21 days for up to 4 doses) for whole-exosome sequencing (WES) and RNA-seq. Results: Twenty-one of 30 pts have been enrolled. Nine (43%) have received all 4 doses of IPI. IPI was discontinued prematurely in 9 pts (43%) due to drug-related toxicities and in 3 (14%) due to disease progression. All 3 of the latter had liver metastases. To date, tumors from 13 pts have been comprehensively analyzed by WES and RNA-seq. The median time from IPI #1 to the next systemic therapy for these pts was 24 weeks (IQR, 18.3 – 54.3). Responders (R) were defined as pts whose time to next systemic therapy was > 24 weeks. The median time to next systemic therapy for R (n = 7, 54%) is 55 weeks (IQR, 52.0 – 89.0; 2 pts with ongoing responses) versus 18 weeks (IQR, 10.5 – 23.0) for non-responders (NR; n = 6, 46%). In an analysis of all 13 pts, including those with liver metastases, tumor mutational load and frequency of expressed non-synonymous mutations were similar for R and NR pts. However, a subset analysis, excluding pts with liver metastases, revealed > 100 total mutations and/or > 10 expressed non-synonymous mutations in 7/7 R versus 1/4 NR. Conclusions: For advanced PCa pts without liver metastases, tumor mutational load may be associated with responses to IPI. Identification of immunodominant neoantigens may lead to the development of personalized vaccines to be combined with immune checkpoint therapies for the effective treatment of pts with PCa. Clinical trial information: NCT02113657.
Phase 1-2 study of progesterone receptor (PR) inhibition with extended-release (ER) onapristone (ONA) alone or in combination with abiraterone (AA) in patients (pts) with castration-resistant prostate cancer (CRPC) incorporating plasma DNA analysis to define androgen receptor (AR) status.
Authors: Jayaram Anuradha , Nowakowska Karolina , Mateo Joaquin , Kumar Sanjeev , Hernandez Tatiana , Fulton Ben , Nava Rodrigues Daniel , Riisnaes Ruth , Zukiwski Alexander , Bexon Alice Susannah , Proniuk Stefan , Barranco Charles , Bianchini Diletta , Zafeirou Zafeiris , Perez Lopez Raquel , Tunariu Nina , Pacey Simon , Jones Robert J. , De Bono Johann S. , Attard Gerhardt 
Published: September 2018

5071 Background: An urgent need exists for new therapies after progression (PD) onAA and enzalutamide (ENZ). Increased PR expression or progesterone-activating AR mutations have been associated with resistance to AR targeting. We aimed to test ONA, a type I PR antagonist with clinical activity in PRpos cancers, in AA/enz-resistant CRPC. In a prospectively defined exploratory analysis, we aimed to report outcome by plasma AR status ( pAR). Methods: This was a multi-institution, open label phase I/II clinical trial in pts progressing after ENZ/AA. Pts were first treated with single agent (SA) ONA using a randomised dose escalation design. ONA at 2 doses was then combined with AA (1000mg od with pred 5mg bid) in pts progressing on AA. The primary end-points were safety, pharmacokinetics (PK) and anti-tumor activity split by p AR. Archival and metastatic biopsies were collected when possible and tested for PR status. p AR was studied using previous methods (Romanel STM 2015). Results: 21 pts received SA ONA (5 = 10mg/ 5 = 20mg/ 4 = 30mg/ 4 = 40mg /3 = 50mg BID) and 15 pts received ONA-AA combination (5 = 30mg ONA BID, 10 = 50mg ONA BID). There were not DLTs or significant LFT abnormalities and no G3/4 adverse events (AE), no treatment discontinuations due to AEs and no SAEs considered related to ONA. PK in SA ONA observed active plasma concentrations and no interaction with AA. Of 32 evaluated pts 15 had a 2105T > A (p.L702H) or 2632A > G (p.T878A) AR mutation detected in plasma pre-treatment and 1 had AR copy number gain. PSA declines were not observed with SA ONA but in 2 pts with combination (-30%, -7%) who were AR normal. The rPFS on SA ONA was 2.8 months for AR normal and 2.6 for AR aberrant (Hazard ratio (HR) 1.41; 95% CI, 0.62-3.72; P 0.48) and on combination was 4.4 months for AR normal (8/15) and 2.2 for AR aberrant (7/15) (HR 6.08; 95%CI, 6.32-221.9; P < 0.001). Conclusions: ONA is safe in CRPC as SA and in combination with AA. There was no difference in rPFS by p AR status for SA ONA but on the combination with AA, pts who were plasma AR normal had a significantly longer rPFS. Clinical trial information: NCT02049190.
A randomized, double-blind, phase III study comparing SB3 (trastuzumab biosimilar) with originator trastuzumab in patients treated by neoadjuvant therapy for HER2-positive early breast cancer.
Authors: Pivot Xavier B. , Bondarenko Igor , Dvorkin Mikhail , Trishkina Ekaterina , Ahn Jin-Hee , Im Seock-Ah , Sarosiek Tomasz , Chattopadhyay Sanjay , Wojtukiewicz Marek , Moiseyenko Vladimir , Shparyk Yaroslav V. , Bello Maximino De Guzman , Semiglazov Vladimir , Song Sujeong , Lim Jae Yun 
Published: September 2018

509 Background: SB3, a proposed biosimilar to the originator trastuzumab (TRZ), demonstrated similarity to its originator in terms of biological activities and pharmacokinetic (PK) equivalence. This study compared SB3 to TRZ in terms of efficacy, safety, PK, and immunogenicity in patients treated by neoadjuvant therapy for HER2 positive early breast cancer (NCT02149524). Methods: Phase III, randomized, double blind, multicenter study compared neoadjuvant SB3 or TRZ for 8 cycles concurrently given with chemotherapy (docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide). Then patients underwent surgery followed by 10 cycles of SB3 or TRZ. The primary endpoint was breast pathologic complete response (bpCR) rate. Equivalence was declared if the 90% confidence interval (CI) of the ratio or the 95% CI of the difference of the bpCR rates in the per-protocol set (PPS) were contained within the pre-defined equivalence margins (0.785, 1.546) and (-13%, 13%), respectively. Secondary endpoints were total pathologic complete response (tpCR), overall response rate (ORR), event-free survival, PK, immunogenicity, and safety. Results: 800 patients were included in PPS. The bpCR rates were 51.7% for SB3 and 42.0% for TRZ. The ratio of bpCR rate was 1.259 and its 90% CI was 1.112-1.426, within the pre-defined equivalence margin. The difference of bpCR rate was 10.70% and its 95% CI was 4.13-17.26; the lower margin was contained within, the upper margin was outside the pre-defined equivalence margin. Secondary endpoints were comparable between SB3 vs TRZ: tpCR rate (45.8% vs 35.8%); ORR (96.3% vs 91.2%). Safety was comparable between SB3 vs TRZ during neoadjuvant period: incidence of treatment-emergent adverse events (96.6% vs 95.2%), most commonly neutropenia, alopecia, and nausea; incidence of serious adverse events (10.5% vs 10.7%). PK equivalence was demonstrated and immunogenicity between SB3 vs TRZ was comparable (0.7% vs 0.0%). Conclusions: Equivalence was demonstrated between SB3 and TRZ based on the ratio of bpCR rates. Safety, PK, and immunogenicity were similar. Complete safety and survival data will follow. Clinical trial information: NCT02149524.