bluuebunny/crossref_metadata_2025_split huggingface dataset:
Bevacizumab, pertuzumab, and sandostatin for patients (pts) with advanced neuroendocrine cancers (NET).
Authors: Firdaus Irfan , Shih Kent C. , Zakari Ahmed , Lang Evan Z. , McCleod Michael , Alguire Kathryn B. , Peacock Nancy Walker , Flora Douglas B. , Ruehlman Peter , Earwood Chris , Bendell Johanna C. 
Published: March 2020

4127 Background: Targeted agents are used to treat well-differentiated NET. Octreotide binds somatostatin receptors and improves time to progression (TTP) of carcinoid tumors, and VEGF pathway targeting improves TTP of pancreatic NET. HER2 overexpression is reported in NET, and pertuzumab blocks HER2 receptor dimerization. This phase II trial combined bevacizumab, pertuzumab, and octreotide LAR for pts with advanced NET. Methods: Pts with advanced well-differentiated NET were enrolled. Pts had ECOG 0-1, and normal end-organ function, including left ventricular ejection fraction (LVEF) ≥50%. Pts received bevacizumab 15 mg/kg IV, pertuzumab 420 mg IV (following an 840 mg loading dose) day 1 of a 21 day cycle, and octreotide LAR 30 mg IM every 28 days. Primary endpoint was objective response rate (ORR). Results: Between 6/10 and 4/11, 43 pts enrolled. 22 M/21 F, med age 62 (33-88), 32 (74%) carcinoid, 11 (26%) PNET. 26% had prior sandostatin, 72% prior surgery, 19% prior radiation, 23% with > 2 previous systemic therapies. Treatment-related grade 3 toxicities included: hypertension (28%), LVEF dysfunction (9%) (reversible with trial drug hold), and diarrhea (7%). No grade 4 toxicity was reported. Median treatment duration was 38 weeks (range: 0 – 76). Chromogranin A values were elevated in 27 pts; 59% had decreases during treatment. Seven pts (16%) achieved objective response [CR: 1 carcinoid (2%), PR: 6 (4 carcinoid, 2 PNET) (14%)]. ORR for carcinoid pts was 15.6%. Median PFS for the entire group was 8.2 months (95% CI: 6.3 – NA). PFS for carcinoid pts was 8.5 months (95% CI: 6.3 – NA); PFS for PNET pts was 6.4 months (95% CI: 3.9 – NA). Median OS has not been reached at 14.3 months followup. Conclusions: The ORR of the combination of bevacizumab, pertuzumab, and octreotide LAR in NET pts was encouraging. Particularly the response rate in carcinoid pts appears higher than historical data, warranting further investigation of this regimen in these pts.
Patients with carcinoma of unknown primary and “colon cancer profile”: Clinicopathologic features and survival data.
Authors: Varadhachary Gauri R. , Karanth Siddharth , Hainsworth John D. , Wang Huamin , Carlson Heather R. , Lenzi Renato , Abbruzzese James L. , Raber Martin N. , Greco Frank A. 
Published: March 2020

4130 Background: We have previously proposed a “colon cancer profile” (CCP-CUP) favorable subset. CCP-CUP is ~ 8% of all CUP with features resembling lower gastroinestional cancers. Distinguishing this entity from other CUP pts is of significance given the progress in the treatment of metastatic colorectal cancer (CRC). Additionally, emerging data suggests a high level of agreement between histology+IHC and tissue of origin profiling for CCP-CUP. Methods: The retrospective cohort includes 74 pts from MD Anderson (50) and Sarah Cannon (24) Cancer Centers from 2004 -2010. Pts with CDX2+ tumors and pathology suggesting a "GI profile" were chosen. All pts met the definition of CUP and most had a negative colonoscopy. Results: 2 cohorts were created - Cohort 1 (34 pts), labeled “consistent with lower GI profile” [CDX2+, CK20+, CK7-] and Cohort 2 (40 pts), labeled “probable lower GI profile” [CDX2+, irrespective of CK7/CK20 status]. Most pts had a good PS; 58% women, median age 59 yrs; 20 (27%) pts had ascites on presentation and the predominant sites of metastases included liver (30%), carcinomatosis (50%), and nodes (51%). 53 pts received first line CRC regimens (FOLFOX or FOLFIRI based), 15 pts received gemcitabine or taxane based and 3 ‘other’ regimens. OS was 37 mo (C.I 22- 52). 6 of these were "outliers" (Stage 4 NED or indolent pathology). Excluding these, cohorts 1 and 2 had 32 and 36 pts - their OS were 37 and 21 mo respectively. There was no difference in OS of pts with or without ascites on presentation. Kras data was available for 17; 12 were Kras mutant. On multivariate analysis, the factors found to negatively influence survival were age, PS (of 2) and 3 or more sites of disease. Conclusions: Survival of IHC defined CCP-CUP pts (which may include colorectal, appendiceal and small bowel profile) exceeds historical control and illustrates a new "favorable" subset. IHC is not without its limitations – nonetheless, pts with CDX2 + tumors and CUP should undergo evaluation for GI cancers and likely best served with an armamentarium of drugs used for CRC. Since carcinomatosis and liver mets are predominant sites, all patients with abdominal CUP should undergo optimal IHC (CDX-2, CK7, and CK20) testing to rule out a CCP-CUP.
Mutation profling in patients with carcinoma of unknown primary using the Sequenom MassARRAY system.
Authors: Hale Katherine Stemke , Wang Huamin , Karanth Siddharth , Raber Martin N. , Carlson Heather R. , Lenzi Renato , Abbruzzese James L. , Mills Gordon B. , Varadhachary Gauri R. 
Published: March 2020

4131 Background: CUP management may be viewed as an epitome of personalised medicine as we apply our understanding of biological markers to this heterogeneous disease. There is a significant interest in evaluating actionable mutations in various signaling pathways, receptors and downstream effectors in CUP that may help us understand its biology and serve as the basis for unique targeted therapeutic approaches. Sequenom (SQM) Massarray platform enables rapid mutation profiling in solid tumors which we applied to CUP. Methods: 83 CUP samples were sent for DNA mass array analysis. Sequenom was run on 60 samples; 23 samples lacked sufficient quantity or quality of DNA. Data on clinicopathological features was collected. Results: Of the 60 patient samples run on SQM, 16 patients had changes including 11 mutations and 6 polymorphisms . The 6 polymorphisms were in MET . The mutations reported were :RAS (7; 6 KRAS, 1 NRAS), IDH1 (2), PI3K (1) and MET (1). Atleast 50% of the tumors were poorly differentiated. Interestingly, the 2 patients with IDH1 mutations presented with osseous predominant metastatic disease. Of the 6 patients with KRAS mutations, 4 presented with a gastrointestinal profile ( CDX2+ or CK20+) on IHC; in all 4, the DNA sequencing analysis results matched the sequenom results. Conclusions: The (all-comers) overall mutation rate in a heterogenous CUP population is low (11/60, 18%). No "new" low frequency mutations were found using the current panel (Table). Rare and potentially targetable mutations may be identified with a larger panel. Focusing on CUP subsets using this approach may also provide a higher mutational yield. [Table: see text]
Final results of a phase Ib study of tivozanib and FOLFOX6 in patients (pts) with advanced gastrointestinal (GI) tumors.
Authors: Eskens Ferry , Oldenhuis Corina N. , Loos Walter J. , Esteves Brooke , van Doorn Leni , Cotreau Monette M. , Bhargava Pankaj , Zhang Joshua , Strahs Andrew Louis , den Hollander Martha Willemine , Gietema Jourik A. 
Published: March 2020

4132 Background: Tivozanib is a potent, selective, oral small-molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 with a long half-life. A Phase I study found tivozanib's maximum tolerated dose (MTD) to be 1.5 mg/d and responses were observed in pts with colorectal cancer (CRC) and other tumors. Tivozanib has shown additive anti-tumor activity with 5-fluorouracil in a preclinical breast tumor model. FOLFOX6 is a standard chemotherapy for GI cancers. This open-label, Phase Ib study (NCT00660153) sought to determine the MTD, dose-limiting toxicities (DLTs), pharmacokinetics (PK), and anti-tumor activity of escalating doses of tivozanib combined with a modified (m) FOLFOX6 regimen (85 mg/kg2 oxaliplatin) in pts with advanced GI tumors. Methods: Tivozanib was administered once daily in 4-week cycles (3 weeks on, 1 week off) with mFOLFOX6 administered on Days 1 and 15 of each cycle. Pts also received a single dose of tivozanib on day -5 for PK analysis. Pts were allowed to continue tivozanib following discontinuation of mFOLFOX6. Results: Twenty two pts (14:8 male:female; median age 58 years; 91% Caucasian) received tivozanib 0.5 mg (n=9), 1.0 mg (n=3), or 1.5 mg (n=10) and mFOLFOX6. Pts received a median of 5.2 (range 0.0 to 25.1) months of treatment. DLTs were observed in 2 pts on tivozanib 0.5 mg (reversible Grade [Gr] 3 diarrhea and Gr 3/4 transaminase elevations) and in 2 pts on tivozanib 1.5 mg (Gr 3 seizure and reversible Gr 3 vertigo). Other Gr 3/4 drug-related adverse events (AEs) included neutropenia, fatigue, and hypertension (n=2 each). Eight pts discontinued treatment due to AEs. The MTD for tivozanib with mFOLFOX6 was 1.5 mg. The disease control rate was 63% (<1% complete response, 27% partial response, 36% stable disease). Preliminary PK data showed no interaction between tivozanib and mFOLFOX6. Eight additional pts enrolled at the 1.5 mg dose level are currently being evaluated. Final results will be presented. Conclusions: Tivozanib can be combined at its recommended dose of 1.5 mg/day with mFOLFOX6 for pts with advanced GI tumors. The combination was tolerable and showed encouraging anti-tumor activity. A Phase II study of this combination for mCRC is ongoing.
Axitinib for first-line metastatic renal cell carcinoma (mRCC): Overall efficacy and pharmacokinetic (PK) analyses from a randomized phase II study.
Authors: Rini Brian I. , Grünwald Viktor , Fishman Mayer N. , Melichar Bohuslav , Ueda Takeshi , Karlov Petr A , Bair A H. , Chen Ying , Kim Sinil , Jonasch Eric 
Published: March 2020

4503 Background: Axitinib is a potent, selective, second-generation inhibitor of vascular endothelial growth factor receptors with efficacy in mRCC. Due to PK and pharmacodynamic variability, some patients have sub-optimal drug exposures at the standard 5-mg twice daily (BID) dose. Prior analyses indicated higher drug exposure enhanced efficacy; thus, dose titration based on individual tolerability may optimize exposure and improve outcomes. A randomized phase II trial evaluated the efficacy and safety of axitinib dose titration from 5 mg BID to a maximum of 10 mg BID in first-line mRCC. Methods: Patients with treatment-naïve mRCC received axitinib 5 mg BID for a 4-week lead-in period (cycle 1). Then, patients with 2 consecutive weeks of blood pressure (BP) ≤150/90 mmHg, no axitinib-related toxicities >grade 2, no dose reductions, and ≤2 antihypertensive medications were randomized in a double-blind fashion to axitinib 5 mg BID + dose titration with either axitinib (arm A) or placebo (arm B); those ineligible for randomization continued with same dose (arm C). Primary endpoint is objective response rate (ORR). Serial 6-hr PK sampling and 24-hr ambulatory BP monitoring (ABPM) were performed on cycle 1 day 15 in a subset of patients. Results: In all, 203 patients were accrued; 112 randomized to arms A or B, and 91 in arm C. As of July 1, 2011, ORR (95% confidence interval [CI]) was 40.2% (31.0, 49.9) in A+B (blinded pooled analysis) and 56.0% (45.2, 66.4) in C. Median progression-free survival (mPFS) (95% CI) was 13.7 mo (9.2, not estimable [NE]) in A+B and 12.2 mo (8.6, 16.7) in C. Patients with drug exposure above therapeutic threshold (AUC24 ≥300 ng·h/mL; n=27) on cycle 1 day 15 had longer mPFS and higher ORR than those with sub-therapeutic exposure (n=25) (mPFS [95% CI]: 13.9 mo [12.2, NE] vs 8.3 mo [5.5, NE]; ORR: 59% vs 48%). Patients with mean increases of diastolic BP (ΔdBP) ≥15 mmHg (n=18) per ABPM had higher ORR than those with ΔdBP <15 mmHg (n=36) (61% vs 53%). Conclusions: Axitinib is effective in first-line treatment of mRCC, with high ORR and mPFS >1 yr. Preliminary results suggest therapeutic drug exposure and ΔdBP ≥15 mmHg on cycle 1 day 15 may be associated with better outcomes.
Biomarker analysis and final results of INT70/09 phase II proof-of-concept study of pazopanib (PZP) in refractory urothelial cancer (UC).
Authors: Necchi Andrea , Zaffaroni Nadia , Mariani Luigi , Schwartz Lawrence H. , Nicolai Nicola , Giannatempo Patrizia , Crippa Flavio , Morosi Carlo , Gianni Alessandro M. , De Braud Filippo G. , Salvioni Roberto 
Published: March 2020

4507 Background: Discouraging results have been achieved with standard and novel compounds in refractory UC. The final results with biomarker analysis of INT70/09 trial with pazopanib are presented. Methods: Pts failing ≥ 1 chemotherapy regimen for metastatic disease underwent PZP 800 mg once daily until PD or unacceptable toxicity. CT scan and PET scan were planned at baseline and q4weeks thereafter. Independent review of all CT scans was made and ≥ 5 RECIST CR+PR were required to conclude for activity according to Simon’s 2-stage design. 50 mL of EDTA blood samples were collected at baseline and q4wks in all pts to analyze plasma VEGF, sVEGFR-1,-2 and -3, c-Kit, IL-6, 8 and 12 by multiplex ELISA plates. Results: 41 pts were enrolled from 02/2010 to 07/2011. 15 pts (37%) had UC of the upper urinary tract. 20/41 pts were treated in 3rd line or beyond. 19 pts (46%) were CDDP-refractory and 22 (54%) had hepatic metastases. 27 (66%) had ECOG PS 1-2. 7 pts (17%) had a confirmed PR, 24 had a SD (76% clinical benefit). 20 pts (49%) had a confirmed necrotic evolution of metastases and/or a decreased SUV at PET consistent with PR. Median PFS and OS (95% CL) were 2.6 (1.7-3.7) and 4.7 mos (4.2-7.3), respectively but 7 pts (17%) had long-term cure for >10mos (4/7 beyond 2nd line). G3 hypertension occurred in 2 pts, diarrhoea in 5, anemia and hand-foot syndrome in 3 pts each. Significant increase from T0 (baseline) to T1 (+4wks) level was observed for VEGF (p<0.0001), IL6 (p<0.0129) and IL8 (p<0.0013) and decrease for VEGFR2 and c-Kit (p<0.0001 each). Rising IL8T1 levels significantly associated with RECIST progression at covariance analysis (p=0.0104). Elevated IL8T1 levels (IQ range, HR=2.11), liver mets (HR=2.33), PS (HR=3.73) and upper tract UC (HR=0.33) were significant variables for OS at multivariate Cox analysis. Conclusions: This is the 1st trial ever presented to meet the primary endpoint with a targeted drug in UC. A role for antiangiogenesis in UC has been set. Increasing levels of IL8 were associated with PD and worse outcome and may be included in a new prognostic model. Future investigation should aim at targeting IL8 to improve efficacy results by prolonging responses.
Primary, secondary, and quality-of-life endpoint results from the phase III AFFIRM study of MDV3100, an androgen receptor signaling inhibitor.
Authors: De Bono Johann Sebastian , Fizazi Karim , Saad Fred , Taplin Mary-Ellen , Sternberg Cora N. , Miller Kurt , Mulders Peter , Chi Kim N. , Armstrong Andrew J. , Hirmand Mohammad , Selby Brian , Scher Howard I. ,   for the AFFIRM Investigators
Published: March 2020

4519^ Background: MDV3100, a novel androgen receptor signaling inhibitor (ARSI), inhibits: 1) binding of androgens to AR, 2) AR nuclear translocation, and 3) association of AR with DNA. MDV3100 was active in a phase I-II trial enrolling pre- and post-docetaxel castration-resistant prostate cancer (CRPC) patients. The AFFIRM trial evaluated whether MDV3100 could provide benefit to men with post-docetaxel CRPC. Methods: In this double-blind, multinational phase III study, patients who had received docetaxel-based chemotherapy were randomized 2:1 to MDV3100 160 mg/day or placebo. Treatment with corticosteroids was allowed but not required. Patients were stratified by baseline ECOG and mean brief pain inventory score. The primary endpoint was overall survival (OS). Other efficacy endpoints included radiographic progression-free survival (rPFS), time to PSA progression (TTPP), soft tissue objective response (PR+CR), PSA response, and quality of life (QoL) response (FACT-P). Results: 800 patients were randomized to MDV3100 and 399 to placebo with respective median treatment durations of 8.3 and 3.0 months.Based on a planned interim analysis at 520 deaths, the Independent Data Monitoring Committee recommended the study be unblinded and placebo patients offered MDV3100. Efficacy results are presented (Table). The most common MDV3100 events with an incidence higher than placebo were fatigue (34% vs 29%), diarrhea (21% vs 18%), and hot flush (20% vs 10%). Grade >3 events of interest were cardiac disorders (0.9% MDV3100 vs 2% placebo), fatigue (6% MDV3100 vs 7% placebo), seizure (0.6% MDV3100 vs. 0% placebo), and LFT abnormalities (0.4% MDV3100 vs 0.8% placebo). Conclusions: MDV3100, a novel ARSI, is well-tolerated and significantly prolongs OS, slows disease progression, and improves QoL in men with post-docetaxel CRPC. [Table: see text]
Effect of neoadjuvant abiraterone acetate (AA) plus leuprolide acetate (LHRHa) on PSA, pathological complete response (pCR), and near pCR in localized high-risk prostate cancer (LHRPC): Results of a randomized phase II study.
Authors: Taplin Mary-Ellen , Montgomery Robert B. , Logothetis Christopher , Bubley Glenn J. , Richie Jerome P. , Dalkin Bruce L. , Sanda Martin G. , Loda Massimo F. , True Lawrence D. , Troncoso Patricia , Genega Elizabeth M. , Balk Steven P. , Nelson Peter , Xie Wanling , Haqq Christopher M. , Tran Namphuong , Liu Cameron S. , Kheoh Thian San , Molina Arturo , Kantoff Philip 
Published: March 2020

4521 Background: LHRPC is infrequently cured with prostatectomy (RP). To date neoadjuvant androgen deprivation therapy (ADT) has not improved outcomes and residual intra-prostatic androgens remain. AA lowers serum testosterone (T) and DHT to < 1 ng/dL and has improved survival in advanced PC. Methods: We conducted a neoadjuvant, phase II trial of AA/LHRHa in LHRPC. The primary aim was to evaluate intra-prostatic T/DHT with LHRHa vs LHRHa/AA. We report secondary endpoints of PSA, pCR and near pCR ([≤ 5mm residual tumor]) and safety. Eligibility: ≥ 3 positive biopsies and either Gleason ≥ 7 (4+3), T3, PSA ≥ 20 ng/mL or PSA velocity > 2 ng/mL/year. For the first 12 wks men were randomized to LHRHa or LHRHa/AA/prednisone (P) 5mg qd. After 12 wks, a prostate biopsy was done to measure T/DHT. Men received 12 more wks of LHRHa/AA/P followed by RP. Results: 58 men enrolled: 28 to initial LHRHa and 30 to initial AA/LHRHa. 2 withdrew prior to RP (1/group). Median age was 58 (50-75). pCR/near pCR was 14/56 (25%). Grade 3 AEs included elevated AST/ALT 5/58 (9%) and hypokalemia 3/58 (5%). No grade 4 mineralocorticoid-related AEs were observed. Conclusions: Neoadjuvant ADT with AA was well tolerated in LHRPC. PSA (<0.2) declines were high and achieved earlier on AA/LHRHa compared to LHRHa. The pCR/near pCR rates were higher for 24 wks AA (34%) than 12 wks AA (15%). No new safety signals were seen with AA used with P 5 mg. These results support further evaluation of aggressive ADT as neoadjuvant/adjuvant therapy for LHRPC. [Table: see text]
Five years into the national second-opinion project of the German Testicular Cancer Group (GCTSG): Impact on guideline implementation and the quality of care for testicular cancer patients.
Authors: Zengerling Friedemann , Hartmann Michael , Heidenreich Axel , Krege Susanne , Albers Peter , Karl Alexander , Wagner Walter , Bedke Jens , Schmelz Hans U. , Retz Margitta , Kliesch Sabine , Winter Eva , Kuczyk Markus , Schrader Mark ,   on behalf of the German Testicular Cancer Study Group (GTCSG), supported by the German Cancer Aid
Published: March 2020

4530 Background: The diagnosis and therapy of testicular germ cell tumors are subject to constant change. Numerous national and international guidelines have been published since the 1990s in order to meet this challenge. It is questionable, however, whether mere publication of guidelines will lead to their implementation. The aim of the present project of the GTCSG was to establish a national second-opinion network in order to improve the implementation of guidelines and the quality of care. Methods: Before determining the primary therapy, participating urologists could communicate with one of 30 second-opinion centers (SOC) via an internet-based platform. The data set comprised the primary clinical, radiological and pathohistological findings, the therapy planned by the advice seeker (first opinion), the therapy recommended by the SOC (second opinion), and the applied therapy as well as the 2-year follow-up data. Primary end points of the study were congruence between the first and second opinion, treatment changes based on the second opinion, and relapse-free 2-year survival. Results: A total of 1722 SOC requests have been submitted since November 2006. At the time of our data analysis 927 cases were evaluated. The response rate was 75.8% for treatment data and 74.4% for 2-year follow-up data. Advice seekers and SOC had discrepant treatment concepts in 43.3% of the cases; this discrepancy was independent of tumor histology and increased in advanced tumor stages (clinical stage ≥IIa: 52.3% vs. <IIa: 34%; p<0.001, Pearson Χ2 test). The SOC request led to reduction of the applied therapy in 11.4% and intensification in 9.5% of the cases. Progression-free 2-year survival was 92% (112/122) for stage I, 90% (17/19) for stage IIa-IIb, and 65% (17/26) for stage ≥IIc. Conclusions: Guidelines for the treatment of germ cell tumors are inadequately implemented, particularly in advanced tumor stages. Every fifth second opinion resulted in a relevant change in the scope of therapy. Patients whose treatment was congruent with the second opinion had a relapse rate comparable to that of study results in the literature.
Serum tumor marker (STM) decline rates during high-dose chemotherapy (HDCT) to predict outcome for germ cell tumor (GCT) patients (pts).
Authors: Feldman Darren Richard , Voss Martin Henner , Jia Xiaoyu , Van Alstine Lindsay Joy , Patil Sujata , Fischer Patricia , Sheinfeld Joel , Bosl George J. , Motzer Robert John 
Published: March 2020

4532 Background: STM decline rates predict outcome for GCT pts during 1st-line conventional-dose chemotherapy. We investigated the importance of STM decline rates during salvage HDCT. Methods: HDCT included an initial low dose (LD) portion (1-2 cycles of paclitaxel plus ifosfamide [TI] + G-CSF) for stem cell collection followed by a high-dose (HD) portion (3 cycles of carboplatin + etoposide or TI + carboplatin). Eligible pts had elevated STM (AFP >15 and/or HCG >2.2) at the start of LD and completed ≥1 HD cycle. Slope and t1/2 were calculated for HCG and AFP for cycles 1-2 of LD and HD starting with the peak value during days (d) 1-6 of LD and HD to avoid interference from lysis. T1/2 for AFP ≤7d and HCG ≤3.5d were categorized as satisfactory (SAT); normalization within 7d was also considered SAT, regardless of t1/2. Pts with elevated AFP and HCG had to have adequate decline in both to be considered SAT. Progression-free (PFS) and overall survival (OS) were compared for SAT vs. unsatisfactory (UNSAT) pts using the log-rank test. Results: Of 117 pts (115 male, 105 nonseminoma), the most common primary sites were testis (81) and mediastinum (26). 93, 19, and 5 pts completed 3, 2, and 1 HD cycles, respectively. Overall, 19/117 had SAT decline during LD (19/77 for HCG; 7/57 for AFP). For LD, there was no significant difference in PFS or OS for SAT vs. UNSAT decline. For HD, 17/96 had SAT decline (11/59 for HCG; 9/47 for AFP). SAT overall decline (HCG and AFP) during HD predicted superior PFS (p=0.0025) and OS (p=0.0046) with 2-year (yr) PFS 0.88 (0.59, 0.97) vs. 0.37 (0.26, 0.47) and 3yr OS 0.82 (0.55, 0.94) vs. 0.37 (0.26, 0.48). SAT HCG decline alone also predicted superior PFS (p=0.0018) and OS (p=0.004) with 2yr PFS 0.91 (0.51, 0.99) vs. 0.32 (0.19, 0.46) and 3yr OS 0.91 (0.51, 0.99) vs. 0.35 (0.22, 0.50) whereas only a non-significant trend for improved PFS (p=0.14) and OS (p=0.16) was seen for AFP alone. Conclusions: STM decline rates during the HD portion of salvage HDCT predicts favorable PFS and OS, mostly driven by HCG. However, UNSAT STM decline does not exclude long-term PFS/OS. STM decline rates during the initial LD portion of HDCT programs do not predict outcome; thus, UNSAT LD decline should not prohibit subsequent HDCT.