scholarly journals Comparative analysis of regional chemotherapy methods on an experimental rat model with peritoneal carcinomatosis

2021 ◽  
Vol 67 (1) ◽  
pp. 134-143
Author(s):  
Aleksandr Zakharenko ◽  
Mikhail Beliaev ◽  
Sergei Bagnenko ◽  
Ilia Vervekin ◽  
Galina Iukina ◽  
...  
Keyword(s):  
Peritoneal Carcinomatosis ◽  
Neoadjuvant Treatment ◽  
Regional Chemotherapy ◽  
Laboratory Animals ◽  
Efficacy And Safety ◽  
Blood Tests ◽  
Multi Stage ◽  
Experimental Rat Model ◽  
The Moment ◽  
Intraperitoneal Chemoperfusion

Peritoneal carcinomatosis is a variant of implantation metastasis of tumors sprouting the serous membrane of an organ. At the moment, the most effective treatment for this disease is regional chemotherapy. Systemic chemotherapy is not effective enough. The standard for the treatment of peritoneal carcinomatosis was cytoreductive interventions followed by open or closed hypertermic intraperitoneal chemoperfusion (HIPEC) or pressurized intraperitoneal aerosol chemotherapy (PIPAC). Purpose of the study: in an animal experiment to compare the efficacy and safety of regional chemotherapy methods HIPEC and PIPAC Materials and methods: the study was conducted on 44 rats of Wistar females. To simulate carcinomatosis, a strain of ascites ovarian tumor (OA) from the Russian Oncology Cancer Research Center N.N. Petrova. was used. The safety of the technique was evaluated clinically and based on laboratory blood tests. Efficiency - based on mass spectrometry, pathomorphological data and in assessing the life expectancy of animals. Results: the conducted methods HIPEC (open, closed) and PIPAC have shown their safety in experiments on laboratory animals. The closed HIPEC technique is most effective. The analysis of the incidence of postoperative complications demonstrated a greater aggressiveness of open and closed techniques compared to the more “sparing” PIPAC method. Conclusions: the experiment showed comparable safety of all animals tested. Due to the peculiarities of the technique, the PIPAC method can be used as an option for multi-stage treatment in cases where CPC and HIPEC are not possible due to a high index of peritoneal carcinomatosis, and as a neoadjuvant treatment to prevent peritoneal carcinomatosis. In any case, the prospects for using this method require further research.

740 CAMRELIZUMAB IN COMBINATION WITH PREOPERATIVE CHEMOTHERAPY FOR LOCALLY ADVANCED ESOPHAGEAL SQUAMOUS CELL CARCINOMA: A SINGLE-ARM, OPEN-LABEL, PHASE II STUDY

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Feng Wang ◽  
Yu Qi ◽  
Xiangrui Meng ◽  
Qingxia Fan
Keyword(s):  
Phase Ii ◽  
Preoperative Chemotherapy ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Reduction Rate ◽  
Complete Response ◽  
Pathologic Response ◽  
R0 Resection ◽  
Efficacy And Safety

Abstract   At present, ESCC has a dismal prognosis with huge unmet clinical needs. With the potential benefit of combining PD-1 inhibitor with nCT, we conducted a phase II trial to assess the efficacy and safety of Camrelizumab plus nCT for locally advanced ESCC. Methods 45 patients (pts) with histologically confirmed stage II/III/IVa(cT2-4aN0-3 M0) ESCC were enrolled from February 2020 to March 2021.The study was divided into two stages, stage1: we administered 1 cycle of Camrelizumab for induction therapy (200 mg q2 weeks); stage2: pts received 2 cycle of Camrelizumab (200 mg every 3 weeks) plus docetaxel and nedaplatin, followed by surgery within 4 ~ 6 weeks after neoadjuvant therapy completion. Primary endpoint was major pathologic response (MPR). Secondary endpoints included pathologic complete response (pCR), R0 resection rate, disease-free survival (DFS) and overall survival (OS). Results At the cutoff date of Mar 9, 2021, 45 eligible pts were enrolled, neoadjuvant treatment was completed in 39 pts. Thus far 32 pts were resected, all patients underwent an R0 resection. Postoperative pathology showed that TNM stage decreased in 28 pts with 87.5% reduction rate. 19 pts (59.38%) reached major pathologic response, 9 pts (28.13%) reached pathologic complete response (no surgery related mortality). A total of 75.56% had AEs with 13.33% of grade ≥ 3 AEs. Date for median DFS and OS were not matured. Conclusion Camrelizumab in combination with preoperative chemotherapy followed by surgery for locally advanced ESCC showed promising downstaging effect and MPR with good tolerance, and its efficacy and safety could be further studied in later trials. Clinical trial information: NCT03917966.

scholarly journals Efficacy and Safety of Albumin-Bound Paclitaxel Compared to Docetaxel as Neoadjuvant Chemotherapy for HER2-Negative Breast Cancer

2022 ◽  
Vol 11 ◽  
Author(s):  
Zhi-Dong Lv ◽  
Hong-Ming Song ◽  
Zhao-He Niu ◽  
Gang Nie ◽  
Shuai Zheng ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Neoadjuvant Chemotherapy ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Lymph Node Status ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Paclitaxel Group ◽  
Docetaxel Group

BackgroundNanoparticle albumin-bound paclitaxel (nab-paclitaxel) as neoadjuvant chemotherapy (NAC) for breast cancer remains controversial. We conducted a retrospective study to compare the efficacy and safety of nab-paclitaxel with those of docetaxel as neoadjuvant regimens for HER2-negative breast cancer.MethodsIn this retrospective analysis, a total of 159 HER2-negative breast cancer patients who had undergone operation after NAC were consecutively analyzed from May 2016 to April 2018. Patients were classified into the nab-paclitaxel group (n = 79, nab-paclitaxel 260 mg/m2, epirubicin 75 mg/m2, and cyclophosphamide 500 mg/m2) and the docetaxel group (n = 80, docetaxel 75 mg/m2, epirubicin 75 mg/m2, and cyclophosphamide 500 mg/m2) according to the drug they received for neoadjuvant treatment. The efficacy and adverse events were evaluated in the two groups.ResultsThe pathological complete response (pCR)(ypT0/isN0) rate was significantly higher in the nab-paclitaxel group than in the docetaxel group (36.71% vs 20.00%; P = 0.031). The multivariate analysis revealed that therapeutic drugs, lymph node status, and tumor subtype were the most significant factor influencing treatment outcome. At a median follow-up of 47 months, disease-free survival (DFS) was not significantly different in those assigned to nab-paclitaxel compared with docetaxel (82.28% vs 76.25%; P = 0.331). The incidence of peripheral sensory neuropathy in the nab-paclitaxel group was higher than that in the docetaxel group (60.76% vs 36.25%; P = 0.008), while the incidence of arthralgia was observed more frequently in the docetaxel group (57.50% vs 39.97%; P = 0.047).ConclusionsCompared with docetaxel, nab-paclitaxel achieved a higher pCR rate, especially those patients with triple-negative breast cancer or lymph node negative breast cancer. However, there was no significant difference in DFS between the two groups. This study provides a valuable reference for the management of patients with HER2-negative breast cancer.

The efficacy and safety of anlotinib in neoadjuvant treatment in locally advanced thyroid cancer: A single-arm phase II clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6069-6069
Author(s):  
Naisi Huang ◽  
Guohua Sun ◽  
Yulong Wang ◽  
Jiaying Chen ◽  
Qing Guan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Thyroid Cancer ◽  
Adverse Events ◽  
Objective Response ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Primary Treatment ◽  
Tumor Diameter ◽  
Efficacy And Safety ◽  
Advanced Thyroid Cancer

6069 Background: Surgery is the primary treatment for locally advanced thyroid cancer (TC). For some locally advanced TC, R0/R1 resection could not be achieved at initial diagnosis and neoadjuvant treatment would be an option. However, there is still little evidence regarding neoadjuvant treatment in locally advanced TC. Methods: This single-arm, phase 2 study investigated the efficacy and safety of Anlotinib (12mg orally daily, for two weeks on/on week off) for 2-6 cycles in patients with locally advanced TC in the neoadjuvant setting. Operable patients received surgery after neoadjuvant treatment. The primary endpoint was objective response rate (ORR). Results: A total of 13 patients were included and received an average of 3.5 cycles (range: 3-6 cycles) of Anlotinib treatment. 12 cases were papillary thyroid cancer, and 1 was follicular thyroid cancer. The ORR of Anlotinib was 76.9% with 10 partial response (PR), 2 stable disease (SD), and 1 progressive disease (PD). 8 PR and 1 SD patients received surgery after neoadjuvant treatment, of whom 8 had R0/1 resections and 1 had R2 resection. 2 PR patients refused to have surgery and the rest 2 patients were not operable. The R0/1 resection rate for intent to treat population was 61.5% and for per-protocol population was 72.7%. The maximum reduction in sum of tumor diameter was an average of 34.8% (range: 30.9%-45.5%) for PR patients. Most adverse events were grade 1 or 2. Common adverse events of all grade were hypertension (76.9%), hypertriglyceridemia (69.2%), proteinuria (53.8%), TSH increase (53.8%), cholesterol elevation (53.8%) and hand-foot syndrome (38.5%). The majority of adverse events discontinued after the neoadjuvant treatment stopped. Conclusions: Anlotinib demonstrated antitumor activity in the neoadjuvant treatment in locally advanced TC and the majority of patients achieved R0/1 resection. Adverse events were consistent with the known Anlotinib adverse event profile. These results suggest that Anlotinib neoadjuvant treatment represents a new option for locally advanced TC. Clinical trial information: NCT04309136.

Preliminary results of a randomized phase II study of paclitaxel and bevacizumab ± gemcitabine as first-line treatment for metastatic breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1089-1089
Author(s):  
K. L. Hoelzer ◽  
A. Brufsky ◽  
J. Hainsworth ◽  
J. T. Beck ◽  
R. Whorf ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Metastatic Breast ◽  
Efficacy And Safety ◽  
Randomized Phase Ii ◽  
Superiority Trial ◽  
Ecog Ps

1089 Background: The addition of bevacizumab (B) to paclitaxel (P) results in a significant improvement in PFS in pts with metastatic breast cancer (MBC) (Miller K, et al. New Engl J Med 2007). A randomized Phase II trial examining the efficacy and safety of adding gemcitabine (G) to the PB doublet has completed enrollment. Reported here are preliminary efficacy and safety results. Methods: This is a US, multicenter, randomized, superiority trial. Eligible pts have locally advanced or metastatic breast cancer, ECOG PS 0 or 1, and no prior cytotoxic therapy for metastatic disease. Prior adjuvant or neoadjuvant treatment with a taxane or endocrine therapy is allowed. Pts are randomized to receive P 90 mg/m2 on Days 1, 8, and 15, followed by B 10 mg/kg on Days 1 and 15 of a 28-day cycle, or the same regimen plus G 1,500 mg/m2 on Days 1 and 15. Primary endpoint is response rate according to RECIST criteria. Results: Between May 2006 and February 2008, 189 women were randomized to treatment. The table below summarizes currently available results. Grades 1–2 alopecia occurred in 28% of pts in the PB arm and in 38% of pts in the PB+G arm. One pt (2%) in the PB arm experienced a Grade 3 nosebleed. Grades 3 and 4 thrombotic events occurred respectively in 0% and 2% of pts in the PB arm, and in 3% and 2% of pts in the PB+G arm. Four pts (7%) in the PB arm and 3 pts (5%) in the PB+G arm discontinued due to treatment-related AEs. Three on-study deaths have occurred, none deemed related to study treatment. Conclusions: Study follow-up is ongoing. Full results will be available at the time of the meeting. Therapy with PB ± G is feasible and does not appear to be associated with significant bleeding or thrombotic events. As expected, the addition of G to the PB doublet appears to increase the incidence of neutropenia in pts with MBC. [Table: see text] [Table: see text]

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