tbuckley/cabot-search huggingface dataset:
A phase I/II study of capecitabine (Cape), oxaliplatin (Ox), panitumumab (Pmab), and external beam radiation therapy (RT) for patients with esophagogastric carcinoma (EC).
Authors: Brian G. Czito, Christopher Willett, Manisha Palta, Shannon McCall, Nathan Gee, Herbert Hurwitz, R Edward Coleman, Yousuf Zafar, Paula Kennedy-Newton, Hope Uronis
Journal: Journal of Clinical Oncology (2012)

68 Background: EC is commonly managed with concurrent chemoradiotherapy, with or without surgical resection. The optimal combination and dose of agents is the subject of continued investigation. This study examines chemotherapeutic agents with known efficacy in EC in combination with the EGFR inhibitor panitumumab. Methods: Eligible pts received RT (1.8 Gy qd to 50.4 Gy) combined with concurrent chemotherapy. Dose-level (DL) 1 was cape (625 mg/m2/bid RT days), ox (40 mg/m2 weekly X 6 weeks), and pmab (3.6 mg/kg, weeks 1, 3 and 5). Chemotherapy doses were escalated barring dose limiting toxicity (DLT). The primary endpoint was defining the maximally tolerated dose with this combination. Secondary endpoints included toxicity and radiographic/pathologic response rates. Results: Twenty-nine pts were enrolled. Twenty-five had adenocarcinoma, 24 (83%) were cN+ and 9 (31%) had M1a/b disease. DLT was not encountered in DL 1. Two of 6 patients at DL 2 (cape 825 mg/m2/bid RT days, ox 50 mg/m2 weekly, pmab 4.8 mg/kg, weeks 1, 3 and 5) developed DLT (one hospitalization due to dehydration; one with drug reaction requiring hospitalization). Twenty additional pts were enrolled at DL1. Primary toxicities were EGFR-rash, esophagitis, nausea/vomiting and fatigue. On repeat endoscopy, 16 (55%) had CR, 10 (35%) PR and 2 (7%) SD. Using PERCIST criteria, 12 (41%), 11 (38%), 2 (7%) and 3 (10%) had CR, PR, SD and PD response on restaging PET, respectively. Twenty pts underwent esophagectomy, revealing Gr 0 response (no residual disease) in 9 (45%), Gr 1 (single/microscopic cells) in 3 (15%), Gr 2 (fibrosis &gt; gross disease) in 4 (20%) and Gr 3 (gross residual &gt; fibrosis or no evident response) in 4 (20%). Seven pts (35%) experienced anastomotic leak (2 requiring reoperation and 3 stent placement). Conclusions: Concurrent chemoradiotherapy utilizing capecitabine, oxaliplatin, panitumumab is reasonably well-tolerated and associated with high rates of radiographic, endoscopic and pathologic response. Postoperative anastomotic leak rates were higher than expected. Further study of this regimen in the operative and nonoperative settings is warranted.
Advanced colorectal cancer (CRC) treatment: Seven viewpoints
Authors: A. Jirillo, M. Boscaro, L. M. Pasetto, S. Monfardini
Journal: Journal of Clinical Oncology (2004)

6104 Background: Frequently, data about therapeutic strategies suggested by oncologists are found on questionnaires, analyses, etc. In the present work, the viewpoints of 7 expert oncologists are provided for the first time. On September 16, 2003, the Symposium “What's new on CRC: focus on new advances and ASCO” was contemporaneously held in 10 Italian Cancer Centers. Methods: The present work provides an analysis based on the Symposia syllabuses collecting 7 medical oncologist presentations about: “Advanced CRC Treatment.” Each presentation lasted 30 minutes, the mean slide number was 33 (range 72–17) and the introduction slide number before dealing with the topic was 12 (35–2). Results: Only 3 Speakers provided data about CRC incidence in Italy and only 2 Speakers tackled CRC in elderly patients. Four Speakers dealt with clinical trials lead within their Institutions Seven spoke about biological therapies explicitly quoting the ASCO 2003 abstracts. Six emphasized the role of oral fluoropirimidines. Two Speakers avoided comparisons between Folfiri and Folfox, the two Chemotherapies mainly used in Italy and Europe. Only one author raised the issue of expenses in advanced CRC therapy and tackled the issues of stable disease (when stop Chemotherapy) Only 3 Speakers provided written conclusions on their slides. Conclusions: Although the analysis is limited to slide contents only, and not to what has been said, the following conclusions can be draught: 1.all Speakers highlighted the latest news coming from ASCO; 2.Each Speaker provided his interpretation about the topic, even though they share some text references; 3.Different treatment philosophies exist, anyway: some oncologists tend to stop after the second line and some suggest therapies also in the third line. The problem of the elderly patients is still scantily tackled. Definitive data will be available during the ASCO 2004. No significant financial relationships to disclose.
Correlation between HER2/<i>neu</i> overexpression/amplification and clinicopathologic parameters in advanced gastric cancer (AGC) patients (pts): A prospective study
Authors: C. Gravalos, A. Marquez, R. Colomer, R. Garcia-Carbonero, J. Sastre, F. Rivera, A. Saenz-Cusi, A. Velasco, C. Guzman, A. Jimeno
Journal: Journal of Clinical Oncology (2006)

4089 Background: Trastuzumab is widely used in the treatment of HER2/neu overexpressing breast cancer pts and also exhibits activity in human gastric cancer cells that overexpress HER2/neu. We are conducting a phase II trial to assess the efficacy and tolerance of trastuzumab in combination with cisplatin as first line chemotherapy (CT) in HER2/neu positive AGC. Objectives: To determinate prospectively the frequency of HER2/neu expression and to evaluate the relationship with clinicopathologic characteristics in advanced gastric adenocarcinoma pts. Methods: Pts were screening for HER2/neu expression/amplification. Immunohistochemistry (IHQ) was performed using herceptest. A fluorescence in situ hybridization (FISH) assay was done when IHQ was = 2. HER2/neu expression was considered negative if IHQ = 0, 1 or IHQ = 2 and FISH negative; and positive if IHQ = 2 and FISH positive or IHQ = 3. Results: A hundred and twenty six pts were tested for HER2/neu status between 2/2004 and 12/2005. 96 (76%) males, median age 61 years (range 29–84). Histological characteristics: all were adenocarcinomas and 47% type intestinal, 33% diffuse, 20% unknown. Primary tumor localization was 101 (80%) gastric and 25 (20%) gastroesophageal junction (GEJ). 115 (91%) pts had metastases (47% liver; 45% lymph nodes; 27% peritoneum; 10% lung; 27% others) and 11 (9%) locoregional advanced disease. Prior therapies: 67 pts surgery, 18 adjuvant/neoadjuvant CT and 14 adjuvant irradiation. HER2/neu expression was negative in 109 (86.5%) cases. The positive cases were: type intestinal (15.5%); type diffuse (10%) (p = 0.54); 9% gastric localization and 29% GEJ tumors were HER2/neu positive too (p = 0.01). Conclusions: HER2/neu overexpression/amplification was found in 13.5% of AGC and is more common in gastroesophageal junction cancers. The study is ongoing. [Table: see text]
ATOPIC CONDITIONS, ANTIHISTAMINE USE, AND GLIOMA RISK : PRELIMINARY RESULTS FROM THE GLIOMA INTERNATIONAL CASE-CONTROL STUDY
Authors: E. Susan Amirian, Michael E. Scheurer, Margaret Wrensch, Sara H. Olson, Rose Lai, Daniel Lachance, Georgina Armstrong, Renke Zhou, Joseph Wiemels, Ching Lau, Elizabeth Claus, Jill Barnholtz-Sloan, Dora Il'yasova, Joellen Schildkraut, Richard Houlston, Sanjay Shete, Jonine Bernstein, Robert Jenkins, Faith Davis, Ryan Merrell, Christoffer Johansen, Siegal Sadetzki, Beatrice Melin, Melissa Bondy
Journal: Neuro-Oncology (2013)

ATOPIC CONDITIONS, ANTIHISTAMINE USE, AND GLIOMA RISK : PRELIMINARY RESULTS FROM THE GLIOMA INTERNATIONAL CASE-CONTROL STUDY
Treatment and biology of lymphomatoid granulomatosis
Authors: B. R. Healey Bird, N. Grant, K. Dunleavy, J. Janik, J. Cohen, S. Pittaluga, S. Steinberg, E. Jaffe, W. Wilson
Journal: Journal of Clinical Oncology (2007)

8029 Background: LYG is a rare angiocentric-destructive process with EBV+ B-cells and reactive T-cells. LYG is graded with grades I-II showing rare-moderate large EBV+ B-cells (usually polyclonal or oligoclonal) and grade III showing numerous large EBV+ B-cells (usually monoclonal), likely reflecting progressive transformation. Historically, steroids and/or chemotherapy have a 14 mos median survival. Methods: We are investigating Interferon-a (I-a) for grade I/II and dose-adjusted EPOCH ±Rituximab (R) for grade III LYG. Results: Characteristics of 53 pts are: male sex 68%; median age (range) 46 (17–67) and median ECOG P.S. 1 (0–3). Disease sites include lung 98%, CNS 38%, kidney 15%, skin 17%, liver 19% and nodes 4%. On study LYG grades are I-30%, II-26% and III-44%. Prior treatment was none-28%, chemotherapy± R-34%, and steroids alone-40% of pts. For grades I/II, I-a is begun at 7.5 million IUs TIW and escalated as tolerated until disease regression and continued 1 yr after CR. Of 31 patients treated with I-a, PFS is 62% at the median f/u of 5.3 yrs. Of 25 evaluable pts (3 NE; 3 TE), 60% had sustained CR for a median of 60 mos (4–175). In 9 pts who progressed on I-a, grade III was found in 5. Thus, in 20 pts with only grade I/II, 75% had sustained CR with I-a. In 11 evaluable pts with CNS disease, 81% achieved remission with I-a alone. The median time to remission is 9 mos (3–40) and median I-a dose is 20 MIU (7–40). Among 24 pts receiving DA-EPOCH±R, PFS is 40% at the median f/u of 28 mos. Of 21 evaluable pts (2 NE, 1 TE), 66% achieved CR. OS of all 53 pts is 68% at the median f/u of 4 yrs. Median EBV viral loads in 29 pts at study entry were 18 copies/10e6 genome equivalents (0–22727) (normal&lt;200). Lymphocyte subsets in 30 pts showed a median CD4–428 (24–2322) and CD8–165 cells/mm3 (42–1316). In 12 pts in CR and with serial values, the mean CD8 cells (131 ± 44) (p2= 0.013) but not CD4 cells (65 ± 75) increased with treatment. Conclusions: High dose I-a produces sustained remissions in grade I/II LYG and is effective in CNS LYG. DA-EPOCH±R can produce durable CRs in grade III LYG. We hypothesize LYG emerges in a compromised immune milieu and undergoes progressive transformation if not effectively treated. Historical results suggest steroids may allow transformation by compromising immune function. No significant financial relationships to disclose.
Natural Killer Cells In Pediatric Acute Lymphoblastic Leukemia Patients At Diagnosis Demonstrate An Inhibitory Phenotype and Reduced Cytolytic Capacity
Authors: Rayne H. Rouce, Takuya Sekine, Gerrit Weber, Claude Chew, Katayoun Rezvani, Catherine M. Bollard, Karen R Rabin
Journal: Blood (2013)
A prospective, multi-institutional phase II study of GW786034 (pazopanib) and depot octreotide (sandostatin LAR) in advanced low-grade neuroendocrine carcinoma (LGNEC).
Authors: A. T. Phan, J. C. Yao, D. R. Fogelman, K. R. Hess, C. S. Ng, S. A. Bullock, P. Malinowski, E. Regan, M. Kulke
Journal: Journal of Clinical Oncology (2010)

4001 Background: Current treatments options for advanced LGNEC are limited. Vascular endothelial growth factor (VEGF) pathway inhibitors, including bevacizumab, sorafenib,and sunitinib have shown preliminary evidence of activity in NEC. Additionally, octreotide has cytostatic activity in NEC. Pazopanib is a selective, orally available, small molecule inhibitor of the VEGFR-1, -2, and -3, PDGF-α, PDGF-β, and c-kit tyrosine kinases. We performed a prospective study of pazopanib administered in combination with octreotide in pts with advanced LGNEC. Methods: Pts with either carcinoid (C) or pancreatic NET (PNET) on a stable dose of depot octreotide (LAR) for ≥ 2 months were enrolled at 2 institutions (MDACC, DFCI). Pts with prior VEGF pathway inhibitor treatment were excluded. Pts received pazopanib 800mg PO daily in combination with LAR at their prior dose level. A 2-cohort (C, PNET), 2-stage design was employed, with early stopping if no RECIST-defined response was observed among the first 20 evaluable pts enrolled per cohort. Pts were followed for tumor response, toxicity, and survival. Results: 52 patients enrolled and 51 treated (29 PNET, 22 C) between 4/07 - 7/09. 25 (18 PNET, 7 C) had prior therapy. 46 (26 PNET, 20 C) completed 12 weeks of therapy and undergone response evaluation. No responders in first stage of C cohort, so accrual was stopped at 20 patients. PNET response rate was 17% (5/30) by ITT. There were 5 PR (all were in PNET cohort), 32 SD, 9 PD. Progression free survival (PFS) rate at week 24 was 76% (80% PNET, 71% C). Median PFS times were 12.7 and 11.7 mos, for C and PNET patients, respectively. Optional functional CT (fCT) was used to monitor BF, BV, MTT, and PS in 16 patients; results will be updated. CTC G3/4 toxicities were relatively rare and included: anemia (1), neutropenia (3), hypertriglyceridemia (2), transaminitis (3), fatigue (3), hypertension (6), nausea (1), diarrhea (3), pain (1), rash (1), syncope (1), and confusion (1). Conclusions: Treatment with pazopanib and octreotide is feasible and associated with tumor regression in pts with PNET. Encouraging PFS durations in both C and PNET pts were observed. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis Novartis
Necessity of screening for uterine cervical cancer in women younger than age 3
Authors: M. Futagami
Journal: Journal of Clinical Oncology (2008)

1535 Background: In 2004, Japanese government recommended that screening for uterine cervical cancer should be conducted for women aged 20 to 29 years. The purpose of study is to analyze the results of screening for uterine cervical cancer performed for women younger than age 30. Methods: We examined the data of 651,408 women who received screening for uterine cervical cancer between 1989 and 2003 in Aomori prefecture, Japan. Of those, we examined the data of 124,368 women with abnormal cytodiagnosis. Results: 23,754 women (19.1%) were younger than age 30 and 1,741 (1.4%) were younger than age 20. The ratio of women younger than age 30 has not changed for 15 years. While the frequency with abnormal cytodiagnosis was 2.8% in 1989, it increased to 9.2% in 2003. The frequency of pregnant women with abnormal cytodiagnosis has remained 1 to 5% for 15 years. That of non-pregnant women with abnormal cytodiagnosis was 2% in 1989, but it increased to 11.7% in 2003. While the frequency of women younger than age 20 with abnormal cytodiagnosis was 3.7% in 1989, it increased to 13.2% in 2003. Two hundred fifty-three women younger than age 30 underwent treatment. Their final diagnosis was 205 of CIS, 39 of cervical squamous cell carcinoma, 5 of cervical adenocarcinoma and 4 of other carcinoma. Conclusions: We have to call women younger than age 30 to receive the screening for uterine cervical cancer. No significant financial relationships to disclose.
Phase I study of LDE225 in advanced solid tumors: Updated analysis of safety, preliminary efficacy, and pharmacokinetic-pharmacodynamic correlation.
Authors: H. A. Tawbi, J. Rodon Ahnert, R. Dummer, A. L. Thomas, C. Granvil, Y. Shou, J. Dey, M. M. Mita, D. D. Amakye, A. C. Mita
Journal: Journal of Clinical Oncology (2011)

3062 Background: LDE225 is a potent and selective inhibitor of Smo, a key regulatory protein in the Hedgehog (Hh) signaling pathway, which is linked to the pathogenesis of many human cancers. This open-label, dose-escalation study aims to evaluate the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of LDE225. Methods: Patients (pts) with advanced cancer (n=76) received oral doses of LDE225, ranging from 100 to 3,000 mg QD and 400 and 750 mg BID, on a continuous 28-day dosing schedule, with a single dose PK run-in period. Dose escalations were guided by a Bayesian logistic regression model. Clinical assessments for safety and antitumor activity were performed. Blood was sampled for PK, as were skin and tumor biopsies for PD analysis. Results: LDE225 was well tolerated up to 800 mg QD. At QD doses ≥ 1,000 mg and BID doses ≥ 400 mg, dose-limiting CTCAE G3/4 increases in plasma creatine phosphokinase (CK) associated with myalgia were observed. Treatment-related G1/2 AEs in > 10% of pts include nausea, vomiting, dysgeusia, decreased appetite, myalgia, muscle spasms and fatigue. Systemic exposure of LDE225 increased with increasing dose but was less than dose-proportional. Steady-state concentrations were achieved after 28 days, with a mean effective half-life of approximately 6 days (range: 1–14 days). An association between high systemic drug exposure and dose-limiting CK elevation was identified. Exposure-dependent reduction in Gli-1 mRNA expression was observed in skin and tumor biopsies (up to 95% and 99%, respectively). A link between Hh target gene expression and antitumor activity was demonstrated in pts with medulloblastoma (1 PR and 1 metabolic PR) and advanced basal cell carcinoma (BCC; 1 CR with histologic clearance and 4 PRs). Disease stabilization (> 4 months) in 5 pts (lung adenocarcinoma, spindle cell sarcoma, breast cancer, and BCC [x2]) was also observed. Conclusions: The MTD of LDE225 is 800 mg QD. LDE225 exhibits exposure-dependent target inhibition, a promising antitumor activity that is linked with Hh pathway inhibition, and evidence of histologic clearance in BCC.
Minimal clinically important differences in the Edmonton Symptom Assessment Scale in cancer patients: A prospective study.
Authors: David Hui, Omar M. Shamieh, Carlos Eduardo Paiva, Pedro Emilio Perez-Cruz, Jung Hye Kwon, Mary Ann Muckaden, Minjeong Park, Sriram Yennu, Jung Hun Kang, Eduardo Bruera
Journal: Journal of Clinical Oncology (2015)

9601 Background: ESAS is widely used for symptom assessment in the clinical and research settings. We determined the MCID for improvement and deterioration for each of the 10 ESAS symptoms using the anchor based sensitivity-specificity approach. Methods: This multicenter, prospective, longitudinal study enrolled patients with advanced cancer. ESAS was measured at a first palliative care clinic visit and a second visit 3 weeks later. For each symptom, we assessed the Patient’s Global Impression (PGI) (“better”, “about the same”, or “worse”) at the second visit as the external criterion. We determined the MCID based on the optimal cutoff for sensitivity/specificity in receiver-operating characteristic (ROC) curve using the Youden’s J method. We conducted sensitivity analyses by estimating MCIDs using other anchor-based and distribution-based approaches. The planned sample size was powered to estimate sensitivity/specificity with 80% power at 0.5% significance (accounting for 10 symptoms). Results: Among the 796 cancer patients from 6 centers, the average age was 57 (range 19-85), 380 (48%) were female, and the median duration between the 2 study visits was 21 days (interquartile range 18-28 days). The area under the ROC curve varied between 0.70-0.87, suggesting good responsiveness. For all 10 ESAS symptoms, the optimal cutoff based on the ROC curve was ≥ 1 point for improvement and ≤ -1 point for deterioration, with sensitivities of 59%-85% and specificities of 69%-85%. Sensitivity analyses showed similar findings: in within-patient analysis, the MCIDs varied between 0.8 and 2.2 for improvement and between -0.8 and -2.3 for deterioration; in ½ standard deviation distribution approach, MCID varied between 1.2 and 1.6; in standard error of measurement approach, MCID varied between 1.3 and 1.7. Using ≥ 1 as the MCID cutoff, between 27% and 48% of patients experienced a clinical response. Conclusions: ESAS was responsive to change. The optimal cutoffs were ≥ 1 point for improvement and ≤ -1 point for deterioration for all 10 ESAS symptoms. Our findings have implications for sample size calculations and response determination.
Rectal cancer: Treatment results and prognostic factors. Single center experience with 186 non-metastatic resctable cases
Authors: S. Bazarbashi, A. El Weshi, Y. Khafaga, M. Rahal, K. Rehman, M. Memon, M. Manji, A. Ezzat
Journal: Journal of Clinical Oncology (2005)

3740 Background: The optimal management of rectal cancer (RC) remains a challenge. Up to half of the patients (pts) undergoing curative resection will develop recurrent disease. Aim: To identify treatment outcome and prognostic factors for pts with non-metastatic rectal cancer managed between 1992–1999. Results: A total of 186 pts (92 M, 94 F) were identified. Median age: 56y. Site: rectum (166), recto-sigmoid (20). Median tumor size: 5cm. Distal tumor margin from anal verge (DTMFAN), median: 5cm. Forty pts had elevated base line CEA. Surgery by hospital: KFSH (118 pts), local hospital (68 pts). Treatment: Anterior resection: 66, abdominoperineal resection: 112, local excision: 8, preoperative radiotherapy (preop RT): 83, postoperative RT (postop RT): 75, adjuvant chemotherapy (ACT): 92 pts. pTNM stage at surgery: I (32), II (60), III (81). Histologic grade: I-II (163), III (20). Mucinous component, positive resection margin (+RM) and lympho-vascular invasion (LVI) were seen in 40, 9 and 30 pts respectively. Seventy-five pts relapsed. Median time to relapse: 18m. Relapse pattern: local (L): 35, distant (D): 28, L + D: 12 pts. Incidence of local relapse in the preop and post op groups were 12% and 32% respectively.With median follow-up duration of 53 m (range 2–145), 7-year event free survival (EFS) and overall survival (OS) rates were 50% and 55% respectively. Cox regression hazard model identified the center’s experience (KFSH vs others), early pTN stage, absence of LVI and preop RT as independent variables that favorably influenced EFS and OS. The use of ACT when indicated affected favorably EFS. Conclusions: Local recurrence remains a major problem in the management of RC. Despite being based on retrospective analysis, preop RT and ACT may reduce the incidence of treatment failure and increase survival in RC. No significant financial relationships to disclose.
Randomized phase II/III trial assessing gemcitabine/carboplatin (GC) and methotrexate/carboplatin/vinblastine (M-CAVI) in patients (pts) with advanced urothelial cancer (UC) “unfit” for cisplatin based chemotherapy (CHT): Updated phase II results and risk group analysis of EORTC study 30986
Authors: M. De Santis, J. Bellmunt Molins, R. de Wit, B. Mead, J. M. Kerst, M. Leahy, P. Maroto, I. A. Skoneczna, S. Marreaud, R. J. Sylvester
Journal: Journal of Clinical Oncology (2008)

5031 Background: The primary objective of the phase II part of this study was to evaluate activity and safety of two CHT combinations in pts with UC “unfit” for cisplatin based chemotherapy. Methods: CHT naïve pts with measurable disease and an impaired renal function (GFR<60 but >30 ml/min) and/or performance status 2 were randomized to receive either GC (G 1000 mg/m ² d1&8 and C AUC 4.5) q21days or M-CAVI (M 30 mg/m² d1&15&22, CA AUC 4.5 d1 and VI 3 mg/m² d1&15&22) q28 days. A two stage Bryant and Day design was used with endpoints response and severe acute toxicity (SAE) which were evaluated with respect to renal function, performance status and Bajorin risk groups. Results: 3 of 178 pts from 28 institutions who were ineligible or did not start treatment are excluded. 16/175 pts received only 1 cycle for reasons other than progression or toxicity. SAEs were mucositis gr3, 1.1% vs 5.7%, thrombocytopenia 3/4 with bleeding 18.1% vs 1.1%, neutropenic fever 3/4 5.7% vs 14.9%, renal toxicity 3/4 5.7% vs 8.0% and death due to treatment 2.3% vs 4.6% for GC and M-CAVI, respectively. Overall response rates (ORRs) and SAEs by treatment arm and risk groups are summarized below (see table). Conclusions: Both combinations are active in this well defined group of purely unfit patients. However in pts with PS2 and GFR<60 ml/min or Bajorin risk group 2, ORRs with GC and M-CAVI are low and toxicity high. Alternative treatment modalities should be sought in this subgroup of very poor risk patients. ORRs and SAEs by treatment arm and risk groups Only 1 cycle n=16/175 (%) ORR (%) SAEs (%) PS2 or GFR<60 7/129 (5) 40 16 PS2 & GFR<60 9/46 (20) 26 26 Bajorin 0 4/68 (6) 47 16 1 2/58 (3) 38 16 2 10/49 (20) 20 24 GC 6/88 (7) 42 14 M-CAVI 10/87 (11) 31 23 ORR=overal response rates; SAE=severe acute toxicity Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Eli Lilly Eli Lilly