Detection of Residual Peritoneal Metastases Following Cytoreductive Surgery Using Pegsitacianine, a pH-Sensitive Imaging Agent: Final Results from a Phase II Study
- 15.04.2024
- Peritoneal Surface Malignancy
Erschienen in:
- Verfasst von
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Patrick Wagner, MD
Patrick Wagner, MD
- Department of Surgical Oncology, Allegheny Health Network Cancer Institute, Pittsburgh, USA
-
Edward A. Levine, MD
Edward A. Levine, MD
- Department of Surgical Oncology, Atrium Health Wake Forest Baptist, Wake Forest University, Winston-Salem, USA
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Alex C. Kim, MD
Alex C. Kim, MD
- Division of Surgical Oncology, The James Cancer Hospital and Solove Research Institute, The Ohio State University, Columbus, USA
-
Perry Shen, MD
Perry Shen, MD
- Department of Surgical Oncology, Atrium Health Wake Forest Baptist, Wake Forest University, Winston-Salem, USA
-
Nicole D. Fleming, MD
Nicole D. Fleming, MD
- Department of Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, USA
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Shannon N. Westin, MD
Shannon N. Westin, MD
- Department of Gynecologic Oncology and Reproductive Medicine, MD Anderson Cancer Center, Houston, USA
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Laurel K. Berry, MD
Laurel K. Berry, MD
- Department of Gynecologic Oncology, Atrium Health Wake Forest Baptist, Wake Forest University, Winston-Salem, USA
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Giorgos C. Karakousis, MD
Giorgos C. Karakousis, MD
- Division of Endocrine and Oncologic Surgery, Hospital of the University of Pennsylvania, Philadelphia, USA
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Janos L. Tanyi, MD
Janos L. Tanyi, MD
- Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, USA
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Madeline T. Olson, PhD
Madeline T. Olson, PhD
- OncoNano Medicine, Inc, Southlake, USA
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Brian Madajewski, PhD
Brian Madajewski, PhD
- OncoNano Medicine, Inc, Southlake, USA
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Brian Ostrander, MS
Brian Ostrander, MS
- OncoNano Medicine, Inc, Southlake, USA
-
Kartik Krishnan, MD
Kartik Krishnan, MD
- OncoNano Medicine, Inc, Southlake, USA
-
Charles M. Balch, MD
Charles M. Balch, MD
- Department of Surgical Oncology, MD Anderson Cancer Center, Houston, USA
-
David L. Bartlett, MD
Korrespondierender Autor David L. Bartlett, MD
- Department of Surgical Oncology, Allegheny Health Network Cancer Institute, Pittsburgh, USA
- Erschienen in
- Annals of Surgical Oncology | Ausgabe 7/2024
Abstract
Background
For patients with peritoneal carcinomatosis, extent of disease and completeness of cytoreductive surgery (CRS) are major prognostic factors for long-term survival. Assessment of these factors could be improved using imaging agents. Pegsitacianine is a pH-sensitive polymeric micelle conjugated to the fluorophore indocyanine green. The micelle disassembles in acidic microenvironments, such as tumors, resulting in localized fluorescence unmasking. We assessed the utility of pegsitacianine in detecting residual disease following CRS.
Patients and Methods
NCT04950166 was a phase II, non-randomized, open-label, multicenter US study. Patients eligible for CRS were administered an intravenous dose of pegsitacianine at 1 mg/kg 24–72 h before surgery. Following CRS, the peritoneal cavity was reexamined under near-infrared (NIR) illumination to evaluate for fluorescent tissue. Fluorescent tissue identified was excised and evaluated by histopathology. The primary outcome was the rate of clinically significant events (CSE), defined as detection of histologically confirmed residual disease excised with pegsitacianine or a revision in the assessment of completeness of CRS. Secondary outcomes included acceptable safety and pegsitacianine performance.
Results
A total of 53 patients were screened, 50 enrolled, and 40 were evaluable for CSE across six primary tumor types. Residual disease was detected with pegsitacianine in 20 of 40 (50%) patients. Pegsitacianine showed high sensitivity and was well tolerated with no serious adverse events (SAEs). Transient treatment-related, non-anaphylactic infusion reactions occurred in 28% of patients.
Conclusions
Pegsitacianine was well tolerated and facilitated the recognition of occult residual disease following CRS. The high rate of residual disease detected suggests that the use of pegsitacianine augmented surgeon assessment and performance during CRS.
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- Titel
- Detection of Residual Peritoneal Metastases Following Cytoreductive Surgery Using Pegsitacianine, a pH-Sensitive Imaging Agent: Final Results from a Phase II Study
- Verfasst von
-
Patrick Wagner, MD
Edward A. Levine, MD
Alex C. Kim, MD
Perry Shen, MD
Nicole D. Fleming, MD
Shannon N. Westin, MD
Laurel K. Berry, MD
Giorgos C. Karakousis, MD
Janos L. Tanyi, MD
Madeline T. Olson, PhD
Brian Madajewski, PhD
Brian Ostrander, MS
Kartik Krishnan, MD
Charles M. Balch, MD
David L. Bartlett, MD
- Publikationsdatum
- 15.04.2024
- Verlag
- Springer International Publishing
- Erschienen in
-
Annals of Surgical Oncology / Ausgabe 7/2024
Print ISSN: 1068-9265
Elektronische ISSN: 1534-4681 - DOI
- https://doi.org/10.1245/s10434-024-15165-4
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