Scientific Posters and Presentations

Chemotherapy-Induced Nausea and Vomiting (CINV)

SUSTOL®

Geller RB, Marks SM, Gabrail NY, Lal LS, Mujumdar U, Schwartzberg LS. Evaluation of chemotherapy-induced nausea and vomiting (CINV) events and associated resource utilization for CINV in patients (pts) treated with highly emetogenic chemotherapy (HEC) and carboplatin (Carbo) and palonosetron (palo)-based anti-emetic responses. J Clin Oncol. 2016;34 (suppl). Abstract e21649.

Geller RB, McLaughlin T, McLeod K, Bajaj M, Dakhil SR, Braun E, Chu DT, Gabrail NY, Marks SM, Schwartzberg LS. Real-world effectiveness of palonosetron with a three-drug regimen to prevent chemotherapy induced nausea and vomiting (CINV) following highly emetogenic chemotherapy (HEC). J Clin Oncol. 2016;34 (suppl). Abstract e18231.

Schnadig ID, Braun E, Mosier M, Geller RB, Schwartzberg LS. Effect of APF530 on health-related quality of life (QOL) and other chemotherapy-induced nausea and vomiting (CINV) end points: phase 3 MAGIC trial. J Clin Oncol. 2016;34 (suppl). Abstract e21666.

Schwartzberg LS, Gabrail NY, Hrom JS, Vogelzang N, Mosier MC, Geller RB, Schnadig ID. Phase 3 MAGIC trial of APF530 v ondansetron (Ond) with fosaprepitant (fos) + dexamethasone (Dex) for highly emetogenic chemotherapy (HEC)-induced nausea and vomiting: analysis by age and gender. J Clin Oncol. 2016;34 (suppl). Abstract e21700.

Smith C, Smith M, Holt J. APF530: A novel extended-release formulation of granisetron for 5-day prevention of chemotherapy-induced nausea and vomiting (CINV). Oncol Nurs Forum. 2016;43(2):abstr E-61. Presented at Oncology Nursing Society Congress, April 2016.

Schwartzberg L, Mosier M, Payne Y, Klepper M, Schnadig I. Phase 3 trial of APF530 vs. ondansetron, each with a neurokinin 1 antagonist and corticosteroid, for prevention of chemotherapy-induced nausea and vomiting in highly emetogenic chemotherapy regimens (MAGIC Trial): Outcomes in cisplatin-based regimen. Abstract 5988, Poster 93. Presented at Society of Gynecologic Oncology Annual Meeting 2016.

Boccia R, Gabrail NY, Morrison D, Fu CH, Schnadig ID. APF530: Pharmacokinetics and efficacy of extended-release granisetron injection in the prevention of acute and delayed chemotherapy-induced nausea and vomiting. J Oncol Pharm Pract. 2016; vol 22(2 suppl); p17; CT20. Presented at Hematology/Oncology Pharmacy Association Annual Conference, March 2016.

Schnadig I, Agajanian R, Dakhil S, Taylor C, Wilks S, Cooper W, Mosier M, Payne Y, Klepper M, Vacirca J. Phase 3 comparison of APF530 versus ondansetron, each in a guideline-recommended 3-drug regimen, for prevention of chemotherapy-induced nausea and vomiting due to anthracycline + cyclophosphamide (AC)–based highly emetogenic chemotherapy (HEC) regimens: a post hoc subgroup analysis of the MAGIC trial. P1-10-07. Presented at San Antonio Breast Cancer Symposium, December 2015.

Schnadig I, Agajanian R, Dakhil S, Gabrail N, Smith R, Taylor C, Wilks S, Cooper W, Mosier M, Payne Y, Klepper M, Vacirca J. Phase 3 study of APF530 vs ondansetron with a neurokinin 1 antagonist + corticosteroid in preventing highly emetogenic chemotherapy–induced nausea and vomiting: MAGIC Trial. J Clin Oncol. 2015;33 (suppl 28S). Abstract 68. Presented at American Society of Clinical Oncology Breast Cancer Symposium, September 2015.

Morrison D, Anderson A, Slama M, Guernsey B, Payne Y, Fu CH, Klepper M. Phase 1 bioavailability study comparing two different subcutaneous routes of administration for APF530. Support Care Cancer. 2015; vol 23(suppl 1); S132; abstract 11-16-P. Presented at Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) Annual Meeting, June 2015.

Payne Y, Anderson A, Slama M, Guernsey B, Klepper M, Fu CH. Phase 1 bioavailability study comparing two different subcutaneous routes of administration for APF530. Oncol Nurs Forum. 2015;42(2):abstr 102. Presented at Oncology Nursing Society Congress, April 2015.

Raftopoulos H, Boccia R, Cooper W, O’Boyle E, Gralla RJ. A prospective, randomized, double-blind phase 3 trial of extended-release granisetron (APF530) versus palonosetron for preventing chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: Does a reanalysis using newer ASCO emetogenicity criteria affect study conclusions? J Clin Oncol. 2014;32(suppl):abstr 9648. Presented at American Society of Clinical Oncology Annual Meeting, June 2014.

Boccia R, Cooper W, O’Boyle E. Phase 3 trial of APF530 versus palonosetron in preventing chemotherapy-induced nausea and vomiting: Efficacy in breast cancer patients receiving moderately or highly emetogenic chemotherapy. J Clin Oncol. 2014;32(suppl):abstr 9645. Presented at American Society of Clinical Oncology Annual Meeting, June 2014.

Smith C, Gabrail N. Phase 3 study comparing the efficacy and safety of sustained-release granisetron (APF530) and palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in cancer patients receiving moderately or highly emetogenic chemotherapy. Oncol Nurs Forum. 2014;41(2):abstr 34. Presented at Oncology Nursing Society Congress, April 2014.

Arevalo-Araujo R, O’Boyle E, Cooper W, Robertson P. Recovery of complete antiemetic response with APF530 during treatment with moderately (MEC) and highly (HEC) emetogenic chemotherapy regimens in patients who failed palonosetron. J Clin Oncol. 2013;31(suppl):abstr e20569.

Barr J, O’Boyle E, Johnson M. Phase I, double-blind, placebo-controlled, ascending single subcutaneous dose, safety, tolerability, and pharmacokinetic study of sustained release granisetron (APF530). J Clin Oncol. 2013;31(suppl):abstr e20587.

Boccia R, Cooper W, O’Boyle E. Sustainability of complete responses (CRs) with APF530 (sustained-release granisetron) during multiple cycles of moderately (MEC) and highly (HEC) emetogenic chemotherapy regimens: Results of a randomized phase III trial. J Clin Oncol. 2013;31(suppl):abstr 9626. Presented at American Society of Clinical Oncology Annual Meeting, June 2013.

Gabrail N, Yanagihara R, Cooper W, O’Boyle E, Smith C, Spaczyński M. Pharmacokinetics (PK), tolerability, and efficacy of APF530 in patients receiving moderately (MEC) and highly (HEC) emetogenic chemotherapy: Phase II trial results. J Clin Oncol. 2013;31(suppl):abstr e20518.

Mason J, Moon T, O’Boyle E, Dietz A. Comparison of the effects of subcutaneous APF530, intravenous granisetron, moxifloxacin, and placebo on the QT interval in humans. J Clin Oncol. 2013;31(suppl):abstr e20539.

Raftopoulos H, O’Boyle E, Gralla RJ, Rosenberg M, Barr J. The effect of continuous exposure to serotonin receptor antagonism on delayed emesis: an analysis of 1,535 patients in two randomized clinical trials with granisetron (G), APF530, and palonosetron (palo). J Clin Oncol. 2012;30(suppl):abstr e19635.

Charu V, Gabrail N, Yanagihara R, Clark-Snow R, Rosenberg MJ, O’Boyle E, Barr J. Patient satisfaction with control of emesis following chemotherapy: comparison of APF530, a subcutaneous extended-release formulation of granisetron, versus intravenous palonosetron. Support Care Cancer. 2012;20(suppl 1):abstr 1109. Presented at Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) Annual Meeting, June 2012.

Grous JJ, Riegel E, Gabrail N, Charu V, Arevalo-Araujo R, Yanagihara R, Nguyen A, Robertson P, Cooper B, O’Boyle E, Barr J. Phase III study of sustained release granisetron (APF530) compared to palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV). J Clin Oncol. 2009;27(suppl):abstr 9627. Presented at American Society of Clinical Oncology Annual Meeting, June 2009.

Barr J, O’Boyle EK, Grous JJ. Comparison of sustained-release granisetron (APF530) to a single dose of palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV) following a phase III study. Abstract PA-2. Presented at Chicago Supportive Oncology Conference, 2009.

CINVANTI™

Boccia R, Geller RB, Clendeninn N, Ottoboni T. A retrospective chart review of hypersensitivity and infusion-site adverse events (ISAEs) associated with fosaprepitant IV in patients receiving anthracycline and cyclophosphamide (AC)‒based chemotherapy. Accepted for presentation at Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) Annual Meeting, June 22-24, 2017, Washington DC.

Ottoboni T, Boccia G, Manhard K, Keller MR, Cravets M, Clendeninn N, Quart B. Bioequivalence and safety of HTX-019 (surfactant-free aprepitant IV) and fosaprepitant in healthy subjects. Accepted for presentation at Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) Annual Meeting, June 22-24, 2017, Washington DC.

Ottoboni T, Boccia G, Keller MR, Cravets M, Clendeninn N, Quart B. Bioequivalence of HTX-019 (aprepitant IV) and fosaprepitant in healthy subjects. Presented at Hematology/Oncology Pharmacy Association Annual Conference, March 29-April 1, 2017, Anaheim, CA.

Pain Management

Viscusi E, Onel E, Boccia G, Chu A, Keller MR, Ottoboni T, Patel SS, Cravets M, Manhard K, Quart B. HTX-011, A locally administered analgesic, reduces postoperative pain intensity and opioid use through 72 hours across bony and soft tissue surgical models. Presented at the European Society of Regional Anaethesia & Pain Therapy (ESRA) 2017 Annual Congress, September 2017.

Ottoboni T, Wilker C, Onel E, Chu A, Patel SS, Quart B. Synergistic effect of bupivacaine and meloxicam in HTX-011: animal and clinical studies. Presented at the IARS 2017 Annual Meeting and International Science Symposium, May 2017.

Leiman D, Minkowitz HS, Patel SS, Boccia G; Chu A, Heiner L, Keller MR, Onel E, Ottoboni T, Quart B. HTX-011, a proprietary, extended-release combination of bupivacaine and meloxicam, reduced pain intensity and opioid consumption for 96 hours following abdominoplasty. Presented at 42nd Annual Regional Anesthesiology and Acute Pain Medicine Meeting, April 2017.

Viscusi E, DeLeon-Casasola O, Gan TJ, Onel E, Boccia G, Chu A, Keller MR; Ottoboni T, Patel SS, Quart B. HTX-011, a proprietary, extended-release synergistic combination of bupivacaine and meloxicam for the relief of acute postoperative pain. Presented at 42nd Annual Regional Anesthesiology and Acute Pain Medicine Meeting, April 2017.

Minkowitz HS, Winkle P, Onel E, Boccia G, Chu A, Clendeninn NJ, Keller MR, Ottoboni T, Patel SS, Quart B. Local administration of HTX-011, a long-acting biochronomer®-based bupivacaine/meloxicam combination, in hernia repair provides similar initial results whether injected or instilled. Presented at PAINWeek, September 2016.

Winkle P, Minkowitz HS, Onel E, Boccia G, Chu A, Clendeninn NJ, Keller MR, Ottoboni T, Patel SS, Quart B. Local administration of HTX-011, a long-acting biochronomer®-based bupivacaine/meloxicam combination, in hernia repair; preliminary results of an interim analysis. Presented at PAINWeek, September 2016.