tbuckley/cabot-search huggingface dataset:
HPV prevalence and genotypic distribution in patients with cervical cancer in Bangkok, Thailand.
Authors: Nuttavut Kantathavorn, Natacha Phoolcharoen, Kanyanee Laebua, Sasikarn Chamchod, Poompis Pattaranutaporn, Pornwaree Trirussapanich, Sunanta Rojwatkarnjana, Wandee Udomchaiprasertkul, Siriporn Saeloo, Waraphorn Krongthong
Journal: Journal of Clinical Oncology (2014)

e12510 Background: As Thailand is considering integrating HPV vaccine into the National Immunization Program, the data about HPV prevalence and genotypes in Thai patients with cervical cancer is crucial. This study aimed to determine the HPV prevalence and genotypic distribution in invasive cervical cancer patients who underwent primary treatment at Chulabhorn Hospital, Bangkok, Thailand. Methods: During June 25, 2012 - January 21, 2014, 120 specimens of liquid-based cytology (Surepath, Becton and Beckinson, USA) were collected from consecutive invasive cervical cancer patients at the time of pelvic examination for clinical staging determination and analyzed by linear array HPV genotyping tests (Roche, USA). Seven patients were excluded. Results: Of 113 patients, the mean age was 53.9 years with a range of 26-77 years. HPV infection was detected in 108/113 cases (95.6%). Ninety-three cases (86.1%) were single infections, and 15 cases (13.9%) were multiple infections. HPV16 and HPV18 were the most common subtypes, detected in 51 cases (45.1%), and 20 cases (17.7%), respectively. HPV58, HPV52, HPV33, HPV45, HPV56 and HPV31 were found in 9 (8.0%), 8 (7.1%), 6 (5.3%), 3 (2.7%), 3 (2.7%), and 2 (1.8%) patients. Conclusions: The distribution of HPV genotypes in patients with cervical cancer in this study slightly differed from the worldwide data. Lower prevalence of HPV16/18 and higher frequencies of HPV52 and HPV58 were revealed. Currently available HPV vaccines against HPV16/18 potentially prevent approximately 62.8 % of cases. The next generation HPV vaccine, the 9-valent (6/11/16/18/31/33/45/52/58), may be required to effectively prevent 99/113 (87.6%) of Thai cervical cancer patients.
Neoadjuvant or definitive chemoradiotherapy (CRT) with carboplatin and paclitaxel (CP) in esophageal and junctional tumor: A geriatric oncologic perspective.
Authors: Jane Sze Yin Sui, MinYuen Teo, Joseph Martin, Cormac Small, Oliver J McAnena, Christopher Collins, Maccon M. Keane, Gregory D. Leonard
Journal: Journal of Clinical Oncology (2014)

e15069 Background: CRT with CP has been established as an efficacious and well-tolerated treatment option for non-metastatic oesophageal and junctional tumors. For selected patients (pts) deemed unsuitable for radical resection, a modified regimen as definitive therapy (DEF) has been adopted, as previously reported. This study examined the influence of age in the uptake of CRT with neoadjuvant (NA) intent. Methods: Pts were identified from institutional pharmacy database. Inclusion criteria were: 1) non-metastatic esophageal or esophagogastric tumor and 2) receipt of weekly CP with concurrent radiotherapy. Electronic health records were reviewed to extract pts demographics and clinical details. Intended therapies (NA vs DEF) and actual therapies received were recorded. Pts were divided into ≥70 years old and <70 years old cohort for comparison. An exploratory logistic regression analysis was performed to investigate influence of age and other variables. Results: Between August 2010 and January 2014, sixty-five pts were identified, of which 46 (71%) were males and median age was 69 years (range: 40-83). All pts had ECOG PS of 0-1. Forty-six (71%) were adenocarcinoma. Majority were cT3 (n=54, 87%), while 38 (60%) were cN0. Thirty-two pts (49%) were ≥70 years old. Median Charlson co-morbidity index for the ≥70 cohort was 4 (range: 0 – 8). In the ≥70 group, 14/32(44%) were planned for NA, compared to 24/33(73%) in <70 group (p=.02). Pts proceeding to radical surgery were 10(71%) in ≥70 and 18(75%) in <70 cohort (p>.05). Pts ≥70 and <70 did not proceed to surgery due to disease progression (1 vs 0), co-morbidities (1 vs 5) and declined (2 vs 1). 18/32(56%) in ≥70 and 9/33(27%) <70 were in DEF group. An exploratory multivariate logistic regression analysis identified ECOG PS 0 vs 1 [OR 4.9 (95% CI 1.2 - 22.5)], and Charlson index ≥3 vs <3 [OR 0.2 (95% CI 0.0 - 0.7), p=.02) as predictive for NA therapy but not age, gender, nodal status or histologic subtypes. Conclusions: Even though older pts were less likely to be offered NA CRT, rate of proceeding to surgery was similar. ECOG PS and co-morbidities instead of absolute age were significant predictive factors.
LUC7L2 Is a Novel RNA-Splicing Regulatory Factor Mutated in Myelodysplastic Syndromes
Authors: Courtney Hershberger, James Hiznay, Rosemary Dietrich, Xiaorong Gu, Cassandra M. Hirsch, Amy Graham, Bartlomiej P. Przychodzen, Valeria Visconte, Vera Adema, Yvonne Parker, Hetty E. Carraway, Tomas Radivoyevitch, Mikkael A. Sekeres, Yogenthiran Saunthararajah, Jaroslaw P. Maciejewski, Richard A Padgett
Journal: Blood (2018)
Dendritic cell vaccination in malignant pleural mesothelioma: A phase I/II study.
Authors: Zwi N. Berneman, Paul Germonpre, Manon Thirza Huizing, Ann Van de Velde, Griet Nijs, Barbara Stein, Viggo F. Van Tendeloo, Eva Lion, Evelien L. Smits, Sebastien Anguille
Journal: Journal of Clinical Oncology (2014)

7583 Background: The prognosis of malignant pleural mesothelioma (MPM) is dismal, with a median overall survival from diagnosis of 12 months. New therapeutic approaches are needed. We evaluated the feasibility, safety, immunogenicity and clinical efficacy of consolidative treatment with autologous dendritic cells (DC) electroporated with mRNA encoding the MPM-associated Wilms' tumor 1 (WT1) antigen. Methods: Ten patients (median age 62 [range: 53-73]) with unresectable MPM and non-progressive disease after platinum/pemetrexed-based chemotherapy underwent leukapheresis. CD14+ monocytes were isolated, cultured into mature DC according to our clinical-grade protocol (Van Tendeloo et al. PNAS 2010) and electroporated with mRNA derived from a codon-optimized WT1 construct with a sig-LAMP sequence and a deletion of the nuclear localization signal. Biweekly intradermal vaccinations were administered for an intended period of 6 months, followed by monthly or bimonthly injections. Delayed type hypersensitivity (DTH) was tested, in order to assay in vivo T-cell responsiveness to the DC vaccine. Overall survival was measured from entry into trial. Results: Leukapheresis was successful in all patients, with a mean number of 19.4 ± 6.9 DC vaccines produced (range: 7-29); 3 patients underwent an additional leukapheresis. A mean number of 18.4 ± 10.7 vaccines were administered (range: 5-44). DC vaccination was well-tolerated; no systemic toxicity was recorded; local reactions at the injections sites occurred in all patients, but were mild and self-limiting. At a median follow-up of 22.7 months, 6 patients are alive, 4 have died and median survival has not yet been reached. The 6-, 12- and 18-month survival rates were 100%, 90% and 75%, respectively. Significant DTH responses (i.e. ≥ 10 mm² induration [Disis et al. Clin Cancer Res 2000]) were elicited in all patients except UPN006, who had the lowest survival (7.3 months). Conclusions: WT1-targeted DC vaccination is feasible and well-tolerated in MPM patients. In vivo evidence of vaccine-elicited immunity to the DC vaccine administered was obtained in 9/10 patients. Overall survival data suggest that adjuvant DC-based immunotherapy provides a clinical benefit for patients with MPM. Clinical trial information: NCT01291420.
Metabolic landscape and prognostic value of HER2 in advanced gastric cancer.
Authors: Chan-Young Ock, Tae Yong Kim, Do-Youn Oh, Kyung-Hun Lee, Sae-Won Han, Seock-Ah Im, Tae-You Kim, Yung-Jue Bang
Journal: Journal of Clinical Oncology (2014)

4061 Background: In advanced gastric cancer (AGC), HER2 is a validated therapeutic target. However, the metabolic landscape of AGC based on the HER2 status has not been reported. Furthermore, the prognostic value of HER2 in AGC is under debate. Purpose of this study is to elaborate the metabolic landscape and prognosis based on HER2 status in AGC. Methods: We consecutively enrolled the 615 AGC patients treated with chemotherapy and whose HER2 status was evaluated from 2004 to 2013 (225 HER2+, 390 HER2-). Among them, 248 patients were evaluated with 18F FDG-PET before chemotherapy. Among 225 HER2+ patients, 67 patients were not exposed to any HER2-targeting agents. We analyzed overall survival (OS) according to HER2 IHC, FISH (HER2/CEP17 ratio, HER2 copy number) and maxSUV (mSUV). Results: The mSUV of HER2+ GC was significantly higher than those of HER2- GC (11.2 vs 7.5, p=0.001). Increased HER2 IHC positivity was correlated with higher mSUV (IHC-: 7.4, IHC 1+: 6.5, 2+: 9.4, 3+: 11.2, p=0.001), and high HER2/CEP17 ratio showed the trend for higher mSUV (<2: 8.9, 2-4: 9.2, ≥4: 10.5, p=0.925). Excluding HER2+ patients who received HER2-targeting agents, OS of AGC patients treated with cytotoxic chemotherapy was not different based on HER2 status (HER2+: 12.6 vs HER2-: 12.5 months, p=0.663). In parallel, neither increased HER2 IHC positivity (IHC-: 12.4, IHC 1+: 13.4, 2+: 11.8, 3+: 12.9 months, p=0.891) nor HER2/CEP17 ratio (<2: 12.1, 2-4: 17.8, ≥4: 13.4 months, p=0.448) nor HER2 copy number (copy<4: 11.2, 4-6: 13.0, ≥6: 11.3 months, p=0.273) influenced on OS. However, based on tumor metabolism, patients with higher mSUV showed higher response rate, but worse OS regardless of HER2 positivity (HER2-: mSUV<12.5: 13.4 vs mSUV≥12.5: 8.9 months, p=0.01, HER2+: mSUV<14.3: 18.5 vs mSUV≥14.3: 6.4 months, p=0.001). Conclusions: Tumor metabolism is higher in HER2+ AGC and this metabolic activity influenced on the OS. However, HER2 is not prognostic factor in AGC patients who receive cytotoxic chemotherapy.
Common genetic variants in genes involved in the Hippo pathway: Novel biomarkers in metastatic colorectal cancer patients treated with irinotecan plus cetuximab.
Authors: Diana L. Hanna, Ana Sebio Garcia, Wu Zhang, Dongyun Yang, Fotios Loupakis, Sebastian Stintzing, Stefan Stremitzer, Yan Ning, Yu Sunakawa, Shinichi Yamauchi, Satoshi Matsusaka, Chiara Cremolini, Rita Elie El-Khoueiry, Alfredo Falcone, Heinz-Josef Lenz
Journal: Journal of Clinical Oncology (2014)

e14523 Background: The Salvador-Warts-Hippo is a novel and emerging pathway at the center of several tumorigenic processes such as stem cell maintenance, migration and proliferation. In metastatic colorectal cancer (mCRC), the Hippo pathway might play an important role by inducing the secretion of the epidermal growth factor receptor (EGFR) ligand amphiregulin, thus EGFR cascade activation. Moreover, the KRAS effector RASSF1A can induce apoptosis by activating kinases in the Hippo pathway. In this study, we tested whether single nucleotide polymorphisms (SNPs) in the Hippo pathway predict efficacy of irinotecan plus cetuximab in patients with mCRC. Methods: A total of 71 mCRC KRAS exon 2 and B-Raf wild-type patients treated with irinotecan plus cetuximab were analyzed.DNA was extracted from peripheral blood and genotypes were obtained by direct Sanger sequencing. Fourteen SNPs in eight genes (MST1, MST2, LATS1, LATS2, YAP, TAZ, FAT4, and RASSF1A) involved in the Hippo pathway were evaluated. The SNPs were selected based on previously reported associations and/or potential functionality. Response rate, progression-free survival (PFS) and overall survival (OS) were evaluated. Results: The LATS rs558614 polymorphism was associated with the response: 80% of the patients with a GG genotype responded compared to 20% and 25% for patients with a GA and AA genotypes, respectively; p=0.03. In the univariate analyses, the RASSF1a rs2236947 polymorphism correlated with the PFS and the OS. Patients harboring at least a variant allele A had a median PFS of 6.1 months compared to 3.4 months for the patients harboring a CC genotype (HR: 0.57; log-rank p=0.04). For OS, patients with at least a variant allele A had a median OS of 15.7 months, compared to patients with a homozygous CC genotype whom achieved a median OS of 10.8 months (HR: 0.53; log-rank p=0.05). In the multivariate analyses this association did not retain significance (p=0.08 and p=0.21 for PFS and OS, respectively). Conclusions: Polymorphisms within the RASSF1A and LATS2 genes are promising outcome biomarkers for KRAS exon 2 and B-Raf wild-type mCRC patients treated with irinotecan plus cetuximab. These results warrant further validation.
灾害和冲突知识（三）自然灾害
Authors: Anthony, Redmond, 季业伟（译）, 周元国（校）
Journal: BMJ (2005)

灾害通常被人为地分为自然灾害和人为灾害。但所有灾害从根本上说都是人为的，这取决于人们主动或被迫选择的居住地和居住方式。灾害发生的触发因素可能是一种自然现象，比如地震，但是其影响可能取决于受灾地区本身的防震抗灾能力。
The first implementation of the NIMH FAST-FAIL approach to psychiatric drug development
Authors: Andrew D. Krystal, Diego A. Pizzagalli, Sanjay J. Mathew, Gerard Sanacora, Richard Keefe, Allen Song, Joseph Calabrese, Andrew Goddard, Wayne Goodman, Sarah H. Lisanby, Moria Smoski, Richard Weiner, Dan Iosifescu, John Nurnberger, Steven Szabo, James Murrough, Anantha Shekhar, William Potter
Journal: Nature Reviews Drug Discovery (2018)
Interim Results from an Ongoing Phase 2 Multicenter Study of Tazemetostat, an EZH2 Inhibitor, in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Authors: Vincent Ribrag, Franck Morschhauser, Pamela McKay, Gilles Andre Salles, Connie Lee Batlevi, Anna Schmitt, Herve Tilly, Guillaume Cartron, Catherine Thieblemont, Christophe Fruchart, John G. Gribben, Thierry Lamy, Steven Le Gouill, Reda Bouabdallah, Michael Dickinson, Stephen Opat, Deyaa Adib, Stephen J Blakemore, John Larus, Peter Johnson
Journal: Blood (2018)
Potential drug cost impact of nivolumab (N) in Canada in patients with DNA mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).
Authors: Kiran Virik, James Joseph Biagi, Robert B Wilson
Journal: Journal of Clinical Oncology (2018)

797 Background: The overall 5 year survival for mCRC remains poor (14%) despite the sequential use of chemotherapy and biologic agents. Immunotherapy is a promising treatment option in tumors with a high mutational burden. This includes mCRC DNA mismatch repair deficient tumors (dMMR). These have upregulation of immune checkpoints and a poorer prognosis. The CheckMate 142 phase II trial in pretreated dMMR mCRC patients showed durable responses and disease control across a number of subgroups including BRAF mutant tumors. The use of immunotherapy has an anticipated budgetary impact on health care systems within the context of this potentially funded utilization of N. Methods: An estimation of the N drug cost alone for new cases diagnosed in 2017 and treated upon relapse in Canada was undertaken. A cost estimate for N treatment in the first line of dMMR mCRC in relapses and de novo was undertaken should this be a future option. N cost per patient was calculated based on treatment indication, median number of cycles, standard dose/schedule. The analysis was performed in Canadian dollars ($) and assumed complete drug delivery and uncomplicated cycles. The cost of N was obtained from the pan Canadian Oncology Drug Review (pCODR) cost for N in lung cancer. The number of target patients and N utilization was derived from constructed schema to give a budget impact estimate. Results: Estimated N cost per treated patient is $91,667. The N drug cost for prior second line and third line relapsed chemotherapy treated patients respectively ranges from $23.6 Million (M) – $36.4M and $12.7M – $17.7M. For 1 st line N: the cost of treating early stage dMMR CRC which subsequently recurs would be $49.1M and the cost for treatment of dMMR de novo mCRC would be $24.6M. A sensitivity analysis was performed. Conclusions: Immunotherapy drug costs in dMMR mCRC potentially add a substantial cost burden to the publicly funded Canadian healthcare system. As data evolves, longer duration of therapy and potential first line use will add further to the estimated budgetary impact.
Maintaining Perioperative Hemostasis in Patients with Severe Hemophilia A and Inhibitors Receiving Emicizumab Prophylaxis
Authors: Karen L. Zimowski, Glaivy M. Batsuli, Mark T. Reding, Jatin Rana, Michael U. Callaghan, Kelly Tickle, Shannon L. Meeks, Robert F. Sidonio
Journal: Blood (2018)
The effect of denosumab on kidney function in patients with metastatic breast cancer to bone previously treated with zoledronic acid.
Authors: Sneha Purvey, Konstantinos Leventakos, Mutsa S Munjoma, Michael J Sherman, Sameer Desale, Pia Maarit Herbolsheimer
Journal: Journal of Clinical Oncology (2014)

e20701 Background: Bone metastases are a significant cause of morbidity leading to skeletal related events (SREs) in patients with advanced breast cancer. Denosumab and zoledronic acid (ZA) are used to prevent SREs. Unlike ZA, denosumab is not cleared by the kidneys and therefore, is less likely to cause kidney impairment. Methods: Data on patients with breast cancer treated at MedStar institutions from October 1, 2010 to June 30, 2013 were collected. Patients with bone metastases who had previously been on ZA and switched to denosumab were included in this retrospective study. Kidney function measured by Glomerular Filtration rate (GFR) using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) was calculated at baseline, on ZA and 6 months after switching to denosumab. In addition, corrected serum calcium was measured at baseline, on ZA and denosumab. Data were analyzed by linear regression model using repeated measures ANOVA. In addition, data were collected for potential other causes of kidney damage. Results: 24 patients with adequate documentation were included. The mean age was 66 years (50-78), 58% were Caucasian and 42% were African-American. Mean duration of ZA was 17.8 months. Mean GFR at baseline was 84 mL/min and decreased to 71 mL/min at the end of ZA (p = 0.0002). Mean GFR increased to 78.6 mL/min over 6 months after switching to denosumab (p = 0.0298). Mean corrected calcium before ZA was the same as on ZA (9.64 mg/dL). Mean corrected calcium decreased to 9.36 mg/dL on denosumab (p = 0.05). Conclusions: In our single institution, retrospective study, there was a decline in GFR on ZA and an improvement of GFR on denosumab, both being statistically significant. There was a statistically significant reduction in serum calcium when patients were switched from ZA to denosumab, but there were no events of hypocalcemia. Our data show that switching from ZA to denosumab is a safe strategy in patients who experienced kidney impairment while on ZA and allows for kidney recovery.
Comparing cancer patient and provider perspectives on fatigue and pain.
Authors: Loretta A. Williams, Gerry C. Bohac, Sejal Badre, David Cella
Journal: Journal of Clinical Oncology (2014)

e17680 Background: Estimates of fatigue incidence in patients with cancer range from 17% to 90%, and estimates of pain incidence range from 33% to 64%. In 1997, Vogelzang et al reported that 78% of patients with cancer experienced fatigue and 61% indicated that fatigue adversely impacted daily life more than pain, whereas only 37% of oncologists shared these perceptions. Our study provides an update to these estimates among patients with cancer and healthcare providers (HCPs), which can help prioritize symptom assessment and management in the clinic. Methods: Respondents were recruited from the general US population to provide a random sample of patients with cancer by online survey firms Harris Poll Online and Schlesinger Associates. Oncology HCPs were recruited by Food and Drug Research, Inc. and Toluna, Inc. Surveys were designed to assess the impact of fatigue and pain. The objectives of this study were to determine and compare the perceptions of cancer patients, oncologists, and oncology nurses about the occurrence and impact of fatigue and pain in patients being treated with chemotherapy. Data were summarized by information source and compared across sources. Results: From June to November 2012, of 1,122 eligible patients, 572 (51%) elected not to participate and 550 (49%) completed the survey. Of 533 eligible oncologists and 617 eligible oncology nurses, 400 oncologists and 400 oncology nurses completed the survey. 58.4% of patients reported that fatigue affected their daily life more than pain during chemotherapy versus 28.8% of oncologists and 25.0% of oncology nurses with this perception. 97.5% of patients reported experiencing fatigue and 86.2 % reported pain during chemotherapy. Oncologists and oncology nurses estimated that 77.9% of patients experienced fatigue, and that 43.6% of patients experienced pain, resulting in HCPs underestimating fatigue by 20% (95% CI, 18%-21%) and pain by 43% (95% CI, 39%-46%). Conclusions: This survey demonstrates the importance of fatigue in the daily life of patients with cancer during chemotherapy. HCPs continue to underestimate the prevalence of fatigue and pain in patients with cancer, a finding that should be considered in the assessment and management of treatment-related symptoms.
Transcriptomic Profiling of Circulating Tumor Cells (CTCs) in Multiple Myeloma (MM): A New Model to Understand Disease Dissemination
Authors: Juan José Garcés, Michal Šimíček, Marco Vicari, Lucie Brozova, Leire Burgos, Renata Bezděková, Diego Alignani, Maria Jose Calasanz, Katerina Growkova, Ludek Pour, Rafael Rios, Joaquin Martinez-Lopez, Pamela Millacoy, Luis Palomera, Rafael Del Orbe, Sonia Garate, Laura Blanco, Patricia Maiso, Zuzana Chyra, Alexander Vdovin, Tomas Jelinek, Cirino Botta, Halima El Omri, Xabier Agirre, Felipe Prosper, Roman Hajek, Jesus F San-Miguel, Bruno Paiva
Journal: Blood (2018)
Activity of IMMU-130 anti-CEACAM5-SN-38 antibody-drug conjugate (ADC) on metastatic colorectal cancer (mCRC) having relapsed after CPT-11: Phase I study.
Authors: Efrat Dotan, Jordan Berlin, Alexander Starodub, Michael J. Guarino, Steven J. Cohen, Pius P Maliakal, Serengulam V. Govindan, William A. Wegener, Robert M. Sharkey, David M. Goldenberg
Journal: Journal of Clinical Oncology (2014)

3106 Background: IMMU-130 is an ADC of the humanized anti-CEACAM5 antibody, labetuzumab, linked to the active metabolite of CPT-11, SN-38 (drug-antibody ratio=7.6). In an every other week dosing schedule, neutropenia was dose-limiting. Multiple doses of 12 mg/kg were tolerated with modest activity (1 PR). We are now examining a more frequent dose schedule. Methods: Patients with mCRC refractory to standard therapy, including CPT-11, with elevated blood CEA (>5 ng/mL) enrolled in this phase I trial. Two regimens are under evaluation: 1 x or 2 x weekly for 2 weeks in a 3-week cycle to assess safety and efficacy, and to determine a safe dose for multiple treatment cycles. Results: Thirteen patients were treated twice-weekly at 4, 6, 9, and 12 mg/kg/dose (n = 3, 6, 3, and 1, respectively). Neutropenia is dose-limiting (6 ≥ G2), with manageable G1-2 nausea (7), fatigue (6), vomiting (3), and diarrhea (2 G1-2, 1 G3) observed during treatment. At 12 or 9 mg/kg, dose reductions/delay were required due to ≥ G2 neutropenia. Two patients dosed at 9 mg/kg required dose reduction to 4.5 mg/kg, one completing 21 doses, with a 24% reduction in the target lesions and another with SD after 32 doses. Two of 6 pts in the 6 mg/kg cohort showed a treatment effect following dose reduction for toxicity; one with a 28% reduction in target lesions after 38 doses, and another with 63% reduction in the target lesions (RECIST1.1 PR) after continuing treatment at 3 mg/kg for 27 doses. A 4.0 mg/kg twice-weekly dose level is now under study. In the once-weekly schedule, 3 pts completed 1 cycle at 8 mg/kg, with 1 pt experiencing dose delay/reduction in the subsequent cycle due to Gr 4 neutropenia; 3 more pts are enrolled. CEA blood titers correlated with response. There have been no anti-antibody or anti-SN-38 antibody reactions based on ELISA tests. The Phase II will expand patients at optimal dosing and will assess PK and UGTA1A genotypes. Conclusions: These early results indicate therapeutic activity of IMMU-130 in advanced mCRC patients during Phase I extended dosing, even in patients who are relapsed/refractive to CPT-11, and with manageable neutropenia and GI toxicities. Clinical trial information: NCT1605318.