Strategy and early results of treatment of advanced cervical cancer patients with synchronous cancers observed in PET-CT imaging

5014 Objective: To evaluate the safety and feasibility of laparoscopic extraperitoneal para-aortic lymphadenectomy and to correlate histopathologic findings and preoperative PET-CT imaging in patients with locally advanced cervical cancer. Methods: We performed a prospective study of patients with locally advanced cervical cancer. Patients enrolled underwent laparoscopic extraperitoneal para-aortic lymphadenectomy prior to chemoradiation at our tertiary cancer center from April 2004 to June 2005. All patients had a preoperative CT scan and PET-CT scan. Results: 12 patients were enrolled. One patient did not undergo surgery. No patient had evidence of metastatic disease to the para-aortic area by preoperative CT scan. The median age was 48 years (range, 35–67). 10 patients were diagnosed with squamous cell carcinoma, one patient with adenocarcinoma, and one patient with transitional cell carcinoma. The stage distribution was: IB2 (3), IIA (1), IIB (4), IIIA (1), IIIB (3). The median BMI was 26 (range, 18.6–29.7). Two (18%) of 11 patients had a positive preoperative PET-CT imaging study for disease in the para-aortic lymph nodes. The median time of surgery was 162 minutes (range, 52–247). The median blood loss was 25 mL (range, 10–100). There were no intraoperative complications. No patient required intraoperative blood transfusions. The median length of postoperative stay was 1 day (range, 1–2). There were two patients who developed postoperative lymphocysts requiring drainage. The median number of lymph nodes removed was 11 (range, 4–17). A total of 2 (18%) of 11 patients had evidence of histologically confirmed lymph node metastases. Of these, only one patient had evidence of disease by PET-CT scan. Only one of the two patients with a positive PET-CT scan for disease in the para-aortic nodes, actually had disease confirmed histopathologically. The sensitivity and specificity of PET-CT scan is 50% and 89%, respectively. Conclusions: Laparoscopic extraperitoneal para-aortic lymphadenectomy is safe, feasible and appears to increase the precision of identifying occult metastasis. Further patient accrual will be needed to evaluate the ultimate utility of PET-CT imaging in this setting. No significant financial relationships to disclose.

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Pre-hysterectomy cone biopsy is able to predict response in locally advanced cervical cancer patients submitted to neo-adjuvant chemoradiation

European Journal of Surgical Oncology ◽

10.1016/j.ejso.2013.06.003 ◽

2013 ◽

Vol 39 (9) ◽

pp. 1025-1029 ◽

Cited By ~ 4

Author(s):

F. Fanfani ◽

A. Fagotti ◽

M.L. Gagliardi ◽

G. Ferrandina ◽

G. Monterossi ◽

...

Keyword(s):

Cervical Cancer ◽

Cancer Patients ◽

Locally Advanced ◽

Advanced Cervical Cancer ◽

Adjuvant Chemoradiation ◽

Locally Advanced Cervical Cancer ◽

Cone Biopsy

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Efficacy and safety evaluation of HLX10 (a recombinant humanized anti-PD-1 monoclonal antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy: A single-arm, open-label, phase 2 study.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e17510 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e17510-e17510

Author(s):

Lingying Wu ◽

Xiumin Li ◽

Jing Wang ◽

Lijing Zhu ◽

Ruifang An ◽

...

Keyword(s):

Cervical Cancer ◽

Adverse Events ◽

Cancer Patients ◽

Advanced Cervical Cancer ◽

Phase 2 ◽

First Line ◽

Standard Chemotherapy ◽

Open Label ◽

Phase 2 Study ◽

Line Standard

e17510 Background: Limited effective treatments are available for advanced cervical cancer patients who progress after first-line chemotherapy. Historic data indicate PD-1 antibodies have significant activity in advanced cervical cancer patients. This study was designed to determine the efficacy and safety of HLX10 (a recombinant humanized anti-PD-1 monoclonal antibody) plus albumin-bound paclitaxel in patients with advanced cervical cancer who have progressed on or are intolerant to first-line standard chemotherapy. Methods: This is an ongoing single-arm, open-label, multicenter, two-stage phase 2 study (NCT04150575). 143 eligible patients aged between 18 and 75, with histologically or cytologically diagnosed cervical cancer and positive PD-L1 expression (combined positive score [CPS] ≥1) were planned to be enrolled and given intravenous infusion of HLX10 (4.5 mg/kg) plus albumin-bound paclitaxel (260 mg/m2) every 3 weeks. Stage one (N = 20) was a safety run-in and preliminary efficacy exploration study with primary endpoints of adverse events, serious adverse events and objective response rate (ORR, assessed by IRRC per RECIST v1.1). In this stage, after all patients completed two tumor evaluations (every 6 weeks), a safety evaluation and a preliminary evaluation of anti-tumor efficacy were conducted to determine whether to proceed to the second stage (N = 123). Stage two is a single-arm, open-label, multicenter, phase 2 study with primary endpoint of ORR assessed by IRRC per RECIST v1.1. Results: Here we report the stage one results (safety and preliminary efficacy) of HLX10 in advanced cervical cancer patients. By cut-off date Oct 14, 2020, 21 eligible patients with median age of 50 (range: 31–65) and average CPS of 39.33 were enrolled; the median follow-up duration was 4.34 months. 71.4% patients had ECOG PS 1. The ORR assessed by IRRC and investigators were 52.4% (95% CI: 29.8%, 74.3%) and 42.9% (95% CI: 21.8%, 66.0%), respectively. The most common grade 3 or worse treatment-emergent adverse events (TEAEs) were decreased neutrophil counts (n = 7, 33.3%), decreased white blood cell count (n = 6, 28.6%) and anemia (n = 4, 19.0%). No TEAEs leading to drug discontinuation were observed. One death (multiple organ dysfunction syndrome) possibly related to treatment was reported. Conclusions: Stage one results demonstrated a manageable safety profile and encouraging efficacy (ORR 52.4%) of HLX10 plus albumin-bound paclitaxel in advanced cervical cancer patients who have progressive disease or intolerable toxicity to first-line standard chemotherapy, representing a novel potential treatment option that warranted further investigation. Clinical trial information: NCT04150575.

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Oncothermia in HIV-Positive and -Negative Locally Advanced Cervical Cancer Patients in South Africa

Conference Papers in Medicine ◽

10.1155/2013/293968 ◽

2013 ◽

Vol 2013 ◽

pp. 1-3

Author(s):

Carrie A. Strauss ◽

Jeffrey A. Kotzen ◽

Ans Baeyens ◽

Irma Maré

Keyword(s):

South Africa ◽

Cervical Cancer ◽

Cancer Patients ◽

Standard Treatment ◽

Locally Advanced ◽

External Beam Radiation ◽

Hiv Positive ◽

Advanced Cervical Cancer ◽

Treatment Toxicity ◽

Locally Advanced Cervical Cancer

Aim. Investigate the clinical, economic, and cellular effects of the addition of oncothermia to standard treatment for HIV-positive and -negative locally advanced cervical cancer patients in public healthcare in South Africa. Objectives. Evaluate the effect that the addition of oncothermia has on local disease control, progression-free survival, overall survival at 2 years, treatment toxicity, quality of life, economic impact, and HIV status of participants. Radiobiology investigations will evaluate thermoradiosensitivity and the molecular markers for thermoradiosensitivity. Methodology. Phase III randomised clinical trial involving 236 HIV-negative and -positive stage IIb-III locally advanced cervical cancer patients. Treatment includes cisplatin, external beam radiation, and brachytherapy. The study group will receive oncothermia treatments. Participants will be monitored for two years after completion of treatment. Hypothesis. The addition of oncothermia to standard treatment protocols will result in improved clinical response without increasing treatment toxicity in HIV-positive patients or raising healthcare costs.

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Carboplatin-based neoadjuvant treatment with peripheral blood stem cell and growth factor support in locally advanced cervical cancer patients with bulky metastatic lymph nodes

European Journal of Obstetrics & Gynecology and Reproductive Biology ◽

10.1016/j.ejogrb.2006.04.005 ◽

2007 ◽

Vol 131 (2) ◽

pp. 236-238 ◽

Cited By ~ 2

Author(s):

Gabriella Ferrandina ◽

Alessandro Perillo ◽

Luca Pierelli ◽

Mariagrazia Distefano ◽

Giuseppe D’Agostino ◽

...

Keyword(s):

Cervical Cancer ◽

Stem Cell ◽

Growth Factor ◽

Cancer Patients ◽

Peripheral Blood ◽

Peripheral Blood Stem Cell ◽

Locally Advanced ◽

Neoadjuvant Treatment ◽

Advanced Cervical Cancer ◽

Locally Advanced Cervical Cancer

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Clinical Translational Evaluation of Al18F-NOTA-FAPI for Fibroblast Activation Protein Targeted Tumour Imaging

10.21203/rs.3.rs-231262/v1 ◽

2021 ◽

Author(s):

Shuailiang Wang ◽

Xin Zhou ◽

Xiaoxia Xu ◽

Jin Ding ◽

Song Liu ◽

...

Keyword(s):

Cancer Patients ◽

Fibroblast Activation Protein ◽

Ct Imaging ◽

Whole Body ◽

Tumour Imaging ◽

Tumour Detection ◽

Fibroblast Activation ◽

Tumour Bearing ◽

Pet Ct ◽

18F Fdg

Abstract PurposeIn this study, a novel Al18F-NOTA-FAPI probe was developed for fibroblast activation protein (FAP) targeted tumour imaging, which was available to achieve curie level radioactivity by automatic synthesizer. The tumour detection efficacy of Al18F-NOTA-FAPI was further validated both in preclinical and clinical translational studies. MethodsThe radiolabeling procedure of Al18F-NOTA-FAPI was optimized. Cell uptake and competitive binding assay were completed with U87MG and A549 cell lines, to evaluate the affinity and specificity of Al18F-NOTA-FAPI probe. The biodistribution, pharmacokinetics, radiation dosimetry and tumour imaging efficacy of Al18F-NOTA-FAPI probe were researched with healthy Kunming (KM) and/or U87MG model mice. After the approval of ethical committee, Al18F-NOTA-FAPI probe was translated into clinical for the PET/CT imaging of first 10 cancer patients. ResultsThe radiolabeling yield of Al18F-NOTA-FAPI was 33.8 ± 3.2% through manually operation (n = 10), with the radiochemical purity over than 99% and the specific activity of 9.3-55.5 MBq/nmol. Whole body effective dose of Al18F-NOTA-FAPI was estimated to be 1.24E-02 mSv/MBq, lower than several other FAPI probes ( 68Ga-FAPI-04, 68Ga-FAPI-46 and 68Ga-FAPI-74). In U87MG tumour bearing mice, Al18F-NOTA-FAPI showed good tumor detection efficacy from the results of micro PET/CT imaging and biodistribution studies. In organ biodistribution study of human patients, Al18F-NOTA-FAPI showed lower SUVmean than 2-[18F]FDG in most organs, especially in liver (1.1 ± 0.2 vs. 2.0 ± 0.9), brain (0.1 ± 0.0 vs. 5.9 ± 1.3), and bone marrow (0.9 ± 0.1 vs. 1.7 ± 0.4). Meanwhile, Al18F-NOTA-FAPI do not show extensive bone uptakes, and was able to find out more tumour lesions than 2-[18F]FDG in the PET/CT imaging of several patients. ConclusionAl18F-NOTA-FAPI probe was successfully fabricated and applied in fibroblast activation protein targeted tumour PET/CT imaging, which showed excellent imaging quality and tumour detection efficacy in U87MG tumour bearing mice as well as in human cancer patients.

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