Systemic Intravenous Chemotherapy Research Articles

The efficacy of coaxial percutaneous iodine-125 seed implantation combined with arterial infusion chemotherapy for advanced pancreatic cancer: a randomized clinical trial

Background This study aimed to evaluate the clinical efficacy of coaxial percutaneous Iodine-125 (125I) seed implantation in combination with arterial infusion chemotherapy for the treatment of advanced pancreatic cancer (PC) through a randomized controlled trial. Methods A total of 101 patients with advanced PC were randomized into two groups: control group treated with systemic intravenous chemotherapy and experimental group that received 125I seed implantation in combination with arterial infusion chemotherapy. Outcomes, including tumor control, abdominal pain relief, and survival time were compared between these two groups (Trial Registration No. KYKT2018-65). Results Pretreatment abdominal pain scores were comparable between the two groups, whereas the abdominal pain scores at 1- and 3-month post-treatment were significantly lower in the control group than those in the experimental group (1-month: 3.74 ± 1.54 vs. 4.48 ± 1.46, p = .015; 3-month: 3.64 ± 2.21 vs. 5.40 ± 1.56, p < .001). At 3-month post-treatment, computed tomography (CT) scan revealed a significantly higher disease control rate in the experimental group than that in the control group (94.0% vs. 74.5%, p = .007). The median survival time in the experimental group was significantly longer than that in the control group (15-month vs. 9-month, p < .001). Conclusion The combination of coaxial percutaneous 125I seed implantation with arterial infusion chemotherapy could significantly alleviate abdominal pain, improve tumor control rates, and prolong survival time in patients with advanced PC.

Assessing the efficacy and safety of DEB-BACE combined with intravenous chemotherapy for the treatment of intermediate to advanced lung adenocarcinoma after progression of targeted drug resistance.

8555 Background: To compare the efficacy and safety of drug-eluting bead bronchial arterial chemoembolization (DEB-BACE) combined with intravenous chemotherapy versus systemic intravenous chemotherapy for intermediate to advanced lung adenocarcinoma with positive driver genes after progression of targeted therapy. Methods: A total of 131 patients with intermediate to advanced lung adenocarcinoma were retrospectively recruited from 2018-2022 and divided into Group A (standard chemotherapy regimen, N=62) and Group B (DEB-BACE and intravenous chemotherapy, N=69). The short-term efficacy, hemoptysis remission rate, dyspnea remission rate, and incidence of adverse effects were compared between the two groups using the χ2 test. Survival estimates were performed by Kaplan-Meier, and a Log-rank test was performed to examine survival differences between groups. Results: The three-month disease control rate (DCR: 82.6% vs 58.1%) and objective remission rate (ORR: 60.9% vs 38.7%) were better in group B than in group A (both P&lt;0.05). Median progression-free survival (PFS, 10.0 vs 7.9 months) and median overall survival (OS, 33.0 vs 18.0 months) were better in group B than in group A (both P &lt; 0.05). The PFS rates at 6, 12, and 24 months were 67.3%, 40.8%, and 0.0% and 54.1%, 23.2%, and 0.0% in groups B and A, respectively; and the OS rates at 6, 12, and 24 months were 100%, 95.7%, 72%, 88.6%, 66.1%, and 21.8% in group B and group A, respectively, with statistically significant differences (P &lt; 0.05). Within one month after treatment, group B had better hemoptysis relief (83.3% vs. 20.0%) and dyspnea relief (57.5% vs. 30.0%) than group A (both P &lt; 0.05). During the follow-up period, the incidence of adverse reactions was significantly lower in group B than in group A (P &lt; 0.05). Conclusions: For patients with intermediate to advanced lung adenocarcinoma who have failed to progress on targeted therapy, DEB-BACE combined with intravenous chemotherapy has shown superior efficacy and survival benefit and lower adverse effects, while significantly improving patients' symptoms of hemoptysis and dyspnea, with important application prospects.

Perspectives of pressurized intraperitoneal aerosol chemotherapy in terms of primary ovarian cancer with peritoneal carcinomatosis treatment

The relevance of the problem of increasing the effectiveness of standard treatment of ovarian cancer is determined by the following characteristics of the disease: high one‑year mortality, high recurrence rate and unsatisfactory results of their treatment. Peritoneal carcinomatosis in ovarian cancer occurs in 65–70 % of cases. The standard modern approach to the treatment of ovarian cancer is a combination of surgical treatment and systemic intravenous chemotherapy. At the same time, more than 70 % of ovarian cancer cases are first diagnosed at stages III–IV. However, despite the successes in the field of surgery and drug treatment, the five‑year survival rate is no more than 24 % at the III and 4.6 % at the IV stage of the disease. One of the frontiers of ovarian cancer resistance to therapy is peritoneal carcinomatosis. Its resistance to therapy is due to the low bioavailability of cytostatics in metastases on the peritoneum to almost zero. In order to increase bioavailability, various forms of intra‑abdominal chemotherapy are used. The technique of pressurized intraperitoneal aerosol chemotherapy (PIPAC) has a number of advantages over other methods of intra‑abdominal antitumor treatment. These advantages include the uniform distribution of cytostatics over the peritoneum, the absence of penetration of cytostatics beyond the peritoneum, which allows PIPAC to be combined with systemic chemotherapy, low trauma and good tolerability of the procedure. PIPAC was implemented into clinical practice in 2011, and since then has been widely used in a number of foreign and domestic clinics. The conducted studies confirm the safety of the technique and its effectiveness against peritoneal carcinomatosis. The data of multicenter studies and the analysis of available literature data, as well as the successful own experience of PIPAC use create prerequisites for investigating the effectiveness of intra‑abdominal aerosol chemotherapy under pressure in relation to peritoneal carcinomatosis in ovarian cancer.

Comparison of regional arterial chemotherapy and systemic intravenous chemotherapy for advanced pancreatic cancer: a systematic review and meta-analysis

Chemotherapy is the mainstay of treatment for advanced pancreatic cancer (stage III/IV). However, conventional systemic intravenous chemotherapy (SIC) has been unsatisfactory for pancreatic cancer. In recent years, regional arterial infusion chemotherapy (RAIC) has been clinically used as a new chemotherapy regimen for the treatment of advanced pancreatic cancer, but its efficacy is controversial. The purpose of this study was to evaluate the clinical efficacy and safety of RAIC. We searched literatures in databases such as PubMed, EMBASE, Cochrane Library, Web of Science, and CNKI. After screening, this meta-analysis finally included 9 randomized controlled trials (RCTs) with 444 patients (230 RAIC and 214 SIC). We used the Cochrane Risk of Bias 2.0 tool to assess risk of bias for included RCTs. Outcomes were overall survival (OS), overall response rate (ORR), adverse events rate (AER), and pain remission rate. Outcome indicators used relative risk (RR) and its 95% confidence interval (CI) as effect analysis statistics. The results showed that RAIC had some advantages over SIC in terms of ORR, OS, incidence of leukopenia, and pain remission. In conclusion, compared with SIC, RAIC has better clinical efficacy and lower toxicity in the treatment of advanced pancreatic cancer.

The Efficacy of Alternate Systemic Intravenous Chemotherapy and Intra-arterial Chemotherapy Approach for Eye Globe Salvage in Retinoblastoma.

The advances in the treatment of retinoblastoma have enabled salvaging the globe in advanced stages with intra-arterial chemotherapy (IAC). We developed a strategy of alternate application of systemic intravenous chemotherapy (IVC) and IAC (referred to as alternate systemic IVC and IAC; ASIAC) to reduce central nervous metastases during IAC and examined its efficacy and safety in eye globe salvage in this study. Between January 2010 and February 2021, 43 eyes of 40 patients received ASIAC treatment for retinoblastoma at the Yonsei Cancer Center, Yonsei University Health System. Their medical records were reviewed retrospectively to evaluate the eye salvage rate (ESR), defined from diagnosis to enucleation. High-risk retinoblastoma was defined as group D or E by the International Classification of Retinoblastoma. The study enrolled 38 and five cases of high-risk and low-risk retinoblastoma, respectively. In total, 178 IAC and 410 IVC courses were administered, with a median of 4 (interquartile range [IQR], 3.0 to 5.0) IAC and 9 (IQR, 6.0 to 11) IVC courses per eye, respectively. The 5-year ESR was 60.4%±8.7% for the whole cohort, 100% for low-risk retinoblastoma, and 53.6%±9.8% for high-risk retinoblastoma. Among those diagnosed since 2015, the 5-year ESR for high-risk retinoblastoma was 63.5%±14.0%. Fifteen eyes underwent enucleation; no viable tumor was found in three enucleated eyes. There were no deaths in this cohort. Primary IAC-IVC (i.e., ASIAC) for patients with retinoblastoma was tolerable and effective in salvaging the eye and maintaining survival.

Efficacy and Safety of Super-Selective Bronchial Arterial Infusion Chemotherapy in the Treatment of Advanced Non-Small Cell Lung Cancer

Objective: The objective was to study the effectiveness and safety of super-selective bronchial arterial infusion (SBAI) chemotherapy in the treatment of advanced stage non-small cell lung cancer (NSCLC). Methods: The clinical data of 120 advanced NSCLC patients were retrospectively analyzed. Among them, 60 NSCLC patients were treated with SBAI method, another 60 NSCLC patients received systemic intravenous chemotherapy as the control group. The efficacy and safety between two groups of patients were compared. Results: The objective response rate and disease control rate of NSCLC patients treated with SBAI were significantly higher than those of the control group (p < 0.05). The 3-month progression-free survival (PFS) rate (96.67%) and 6-month PFS rate (86.67%) of the SBAI group were significantly higher than those of the control group (73.33% and 56.67%) (p < 0.01). After treatment, the FACT-L scores of patients in the SBAI group were significantly higher than those of the control group (p < 0.05). The scores of all the 13 core symptom items and six symptom interference items of NSCLC patients in the SBAI group were lower than those of the control group (p < 0.05). The adverse reactions rate in the SBAI group were significantly lower than those in the control group (p < 0.05). Conclusion: The short-term efficacy of SBAI chemotherapy for advanced NSCLC is significantly higher than that of traditional peripheral intravenous chemotherapy, and it can significantly improve patients’ quality of life and reduce the incidence of adverse reactions.

Retinal Optical Coherence Tomography Angiography Findings following Retinoblastoma Treatment by Chemotherapy.

To investigate the macular microvascular changes after different kinds of chemotherapy in patients with extramacular retinoblastoma (RB). In this study, 28 eyes of 19 patients with bilateral RB treated with intravenous systemic chemotherapy (IVSC group) and 12 eyes of 12 patients with unilateral RB treated with intra-arterial chemotherapy (IAC group) were compared with 6 normal fellow eyes of 6 patients with unilateral RB treated with IVSC (IVSC fellow eye group), and 7 normal fellow eyes of 7 unilateral RB patients treated with IAC (IAC fellow eye group), as well as 12 age-matched normal eyes. Enhanced depth imaging optical coherence tomography measurements of central macular and subfoveal choroidal thickness (CMT and SFCT) as well as optical coherence tomography angiography measurements such as retinal superficial capillary density (SCD), deep capillary density (DCD), and choriocapillaris density were documented. Images of 2 eyes in the IVSC group and 8 eyes in the IAC group were excluded from the final image analysis due to severe retinal atrophy. Overall, 26 eyes with bilateral RB treated with IVSC and 4 eyes of 4 patients with unilateral RB treated with IAC were compared with the mentioned control groups. Best-corrected visual acuity was 1.03 logMAR in the IAC patients compared to 0.46 logMAR in the IVSC group at the time of imaging. While the CMT and SFCT were lower in the IAC group in comparison with the IAC fellow eye and normal groups (P < 0.05 for all), no remarkable difference was observed between the IVSC group and the control groups based on the mentioned parameters. Although the SCD showed no significant difference between the IVSC and control groups, this parameter was significantly lower in the eyes receiving IAC relative to the corresponding fellow eye group (P = 0.042) and normal control eyes (P = 0.047). The mean DCD was considerably lower in both the treatment groups compared to the control groups (P < 0.05 for all). Our study showed a substantial decrease in SCD, DCD, CMT, and choroidal thickness in the IAC group, which may explain the lower visual outcome in this group.

Application and prospect of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy in the treatment of peritoneal metastasis from colorectal cancer

Colorectal cancer is one of the common malignant tumors in China, and its incidence is increasing with years. As the second most common metastatic site of colorectal cancer, peritoneum is difficult to diagnose early and with a poor prognosis. Systemic intravenous chemotherapy was used as the main treatment strategy for peritoneal metastasis in the past, but its systemic toxic and side effects were obvious, and it could not effectively control tumor progression. In recent years, the continuous development of surgical techniques, concepts, and equipment, as well as the introduction of new chemotherapy drugs and targeted drugs have significantly improved the quality of life and prognosis of patients with peritoneal metastasis of colorectal cancer. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) can effectively eradicated the intraperitoneal free cancer cells and subclinical lesions, while reducing systemic side effects of chemotherapy drugs, and achieve the radical cure of the tumor at the macro and micro levels to the greatest extent. It has been used as the first-line treatment program for peritoneal metastasis of colorectal cancer at home and abroad. This article focuses on the analysis and summary of the survival efficacy, prognostic factor analysis, and chemotherapy safety of CRS+ HIPEC in the treatment of colorectal cancer peritoneal metastasis. The existing problems and controversies of HIPEC therapy are discussed simultaneously.

Role of hyperthermic intraperitoneal chemotherapy in combination with an intraperitoneal port system in the treatment of patients with advanced ovarian cancer

Background. The survival rate of patients with ovarian malignancies depends on the prevalence of the tumor process, the volume of surgical treatment, and the size of the residual tumor. At the first stage, an «aggressive» surgical tactic of removing all macroscopically determined tumor foci with subsequent antitumor drug therapy is recommended. However, the results of treatment remain unsatisfactory, which dictates the need to search for new methods of treatment.Objective: to evaluate the effectiveness of implantable port systems for intraperitoneal chemotherapy administration in the treatment of patients with advanced stages of ovarian cancer.Materials and methods. 37 cases of stage IIIC ovarian cancer were studied for the period 2018–2019. At the first stage of treatment, a cytoreductive operation was performed. At the second stage, the patients were randomly randomized into three groups: group 1 (n = 9) – installation of a port system + hyperthermic intraperitoneal chemoperfusion followed by intraperitoneal chemotherapy; group 2 (n = 11) – hyperthermic intraperitoneal chemoperfusion followed by systemic intravenous chemotherapy; group 3 (n = 17) – control group, intravenous administration of antitumor drugs. The observation period is 27 months. In the study groups, the indicators of age distribution, the degree of malignancy of the neoplasm, the volume of the residual tumor, and the relapse-free survival were analyzed.Results. Trends towards differences in progression-free survival were found in all study groups. In group 1, there was no relapse in all patients. In group 2, relapses amounted to 18.2 %, in group 3–23.5 %. G3 ovarian cancer (6 (66.7 %) and 6 (54.5 %) cases, respectively) prevailed in groups 1 and 2; G1 ovarian cancer (9 (52.9 %) cases) prevailed in group 3. Discussion. Features of the chemical composition and method of administration of the drug increase the effectiveness of local exposure to tumor cells. The introduction of cytostatic agents into the abdominal cavity leads to minimal systemic toxicity, which exceeds the results of standard intravenous therapy.Conclusion. An advantage in the relapse-free survival of patients after hyperthermic intraperitoneal chemoperfusion in combination with an implantable port system was found in comparison with standard methods of treatment.

Clinical Analysis of 16 Distant Metastatic Retinoblastoma Cases with Event-Free Survival.

AimThis study aimed to summarize the clinical characteristics, treatment, and outcomes of distant metastatic retinoblastoma with event-free survival.DesignRetrospective interventional case series.MethodsWe screened patients with retinoblastoma who survived without events after the comprehensive treatment of distant metastases from June 2015 to February 2021 and collected information regarding their basic characteristics, diagnosis, and treatment. All patients received systemic intravenous chemotherapy. Other treatments included surgical treatment, radiotherapy, intrathecal chemotherapy, and autologous stem cell transplantation.ResultsAmong 780 hospitalized patients with retinoblastoma in the pediatric ward, a total of 94 patients with retinoblastoma were diagnosed with distant metastases, and 16 patients with distant metastatic retinoblastoma who survived more than 6 months without events were screened, including eight male and eight female patients. The median age of onset was 29 (range, 11–120) months. Among the 16 patients, central nervous system metastasis (8/16), bone metastasis (8/16), bone marrow infiltration (4/16), lymph node metastasis (4/16), and parotid gland metastasis (3/16) were presented. All patients received treatment for more than 6 months, completed their regimen by February 2021, and survived without events. The median survival time after the onset of retinoblastoma was 50.5 (range, 23–102) months, the median survival time after metastasis was 43.5 (range, 16–71) months, and the median event-free survival was 29.0 (range, 6–59) months.ConclusionMetastatic retinoblastoma may benefit from comprehensive treatments including systemic intravenous chemotherapy and hematopoietic stem cell transplantation. However, recurrence after treatment still needs attention, and patients in complete remission still need long-term follow-up.

Selective transcatheter arterial infusion of cisplatin in palliative intent for residual bulky tongue cancers after intravenous systemic chemotherapy combined with radiotherapy: Two case reports

Concurrent radiotherapy with Transcatheter Arterial Infusion (TAI) chemotherapy is reportedly effective in curing locally advanced head and neck cancer. However, the effectiveness and safety of using TAI with palliative or salvage intent after radiotherapy combined with systemic intravenous chemotherapy (IV-CRT) is not well known. Herein, we describe two cases using TAI palliatively for locally advanced residual tongue cancer after IV-CRT, where tumor reduction or tumor progress inhibition could be achieved, thereby improving or maintaining the patients’ quality of life without severe toxicities. These cases indicate the effectiveness and safety of using TAI palliatively for locally advanced tongue cancer. Further, we have combined a literature review with the description of these cases. Keywords: tongue cancer; transcatheter arterial infusion; palliative interventional radiology

Computational Fluid Dynamics Study of Superselective Intra-arterial Chemotherapy for Oral Cancer: Flow Simulation of Anticancer Agent in the Linguofacial Trunk

Superselective intra-arterial chemotherapy (SSIAC) for oral cancer can deliver a higher concentration of anticancer agent into a tumor-feeding artery than intravenous systemic chemotherapy. However, the agent distribution between the lingual artery and facial artery (FA) is not clear in SSIAC for patients with the linguofacial trunk. The agent distribution in the SSIAC method was investigated using computational fluid dynamics (CFD). Ten three-dimensional vessel models were created from CT images of two patients with oral cancer (patients A and B) with the linguofacial trunk. Catheter models were combined with vessel models to mimic intra-arterial infusion, and the agent flow was analyzed. In patient A models, the agent distribution varied depending on the catheter tip position in the linguofacial trunk, while all anticancer agents flowed into the FA only in patient B models. This study revealed that the behavior of the agent in the common trunk is determined by the blood flow field which depends on the topography of the vessels in each patient. Therefore, the catheter tip position should be changed according to the vessel topography to deliver anticancer agents into the tumor-feeding artery. Moreover, CFD can be a useful method to predict the agent flow for each patient before SSIAC.

Intravitreal Melphalan for Retinoblastoma: The Impact of Toxicity on Recurrence and Ultimate Globe Salvage

Introduction: Intravitreal melphalan (IVM) has emerged as an efficacious treatment for vitreous seeding in retinoblastoma. Although rarely severe, IVM-related toxicity may be treatment limiting. There is paucity of data on the impact of IVM toxicity on new tumor formation and ultimate globe salvage. Objectives: To investigate whether the grade of retinal toxicity post-IVM impacts retinal and seeding tumor recurrence, as well as the overall ability to salvage the eye. Methods: A single-institution retrospective chart review was performed on 47 eyes of 42 patients who received systemic intravenous chemotherapy followed by IVM as salvage treatment for persistent or recurrent vitreous seeding. Chorioretinal toxicity was graded from 0 to 5. Results: Toxicity grade was inversely associated with the risk of recurrence, where a one-unit increase in toxicity grade correlated with nearly a 54% reduction in the odds of tumor recurrence (OR 0.46 [0.25–0.84], p = 0.01). Similarly, toxicity grade was related to enucleation, where a one-unit increase in toxicity grade was associated with a 31% reduction in the odds of undergoing enucleation (OR 0.69 [0.40–1.18], p = 0.17). Conclusions: While retinoblastoma therapy aims to limit toxicity, especially visually significant toxicity, eyes with higher grades of post-IVM toxicity are less likely to have retinal and seeding tumor recurrence.

Patient‐Reported Toxicity Outcomes Collected from a Diverse Sample of Ambulatory Oncology Practices: Feasibility, Patterns, and Correlates

Research ObjectiveIn the United States, adult patients with cancer receive most chemotherapy treatments in ambulatory settings. Yet outside of clinical trials, these setting rarely collect and report patient‐reported outcomes (PROs), such as treatment‐associated toxicities. As novel cancer treatments expand, we examined the feasibility of collecting PROs from adults with cancer receiving chemotherapy treatment and described the patterns and correlates of patient‐reported toxicities.Study DesignWe conducted secondary data analysis from a multisite study of ambulatory oncology care quality and safety. On‐site practice champions identified eligible patients who completed an anonymous questionnaire at their appointment check‐in. Patients receiving chemotherapy completed 11 items from the Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE), with a recall period of the past seven days. Patients rated each item on a 5‐point scale across three domains: frequency, severity, and interference with daily activities. Patients rated the frequency of nausea, vomiting, diarrhea, and pain (1 = never, 5=almost constantly); the severity of nausea, vomiting, constipation, numbness/tingling, and pain (1 = none, 5 = very severe); and how much numbness/tingling and pain interfered with usual or daily activities (1=not at all, 5=very much). Patients could report two additional side effects in an open‐text section. Descriptive statistics were calculated at both the patient and practice levels to generate practice‐level data summaries.Population StudiedAdults with invasive, nonmetastatic cancer and received systemic intravenous chemotherapy treatment at one of 29 medical oncology practices that participated in a statewide quality improvement collaborative. Patients either read English or had a nonclinician proxy available.Principal FindingsOf 3,565 eligible patients, 2,245 participated (63%). A total of 1,302 (58%) were female, 389 (17%) were nonwhite, and 257 (11%) were treated in rural settings. A total of 457 patients (20%) rated at least one toxicity as severe/very severe. At the practice level, the proportion of patients per practice who reported at least severe/very severe toxicity ranged from eight to 50 percent. The toxicities rated with the highest severity were pain frequency (mean 2.3, SD 1.3), pain severity (2.1, 1.1), and diarrhea frequency (1.9, 1.0). From completed assessments, 1,653 (74%) self‐reported at least one additional toxicity in the open‐text section. After thematic analysis, the most frequently reported toxicities in the open‐text section were fatigue (n=182), generalized stomach discomfort (n=53), and skin/nail changes (n=41). Regarding consequences of toxicities experienced since the last chemotherapy treatment, 156 patients (7%) reported unplanned health care service use for toxicity management: 41 (26%) visited an emergency department, and 32 (21%) were admitted to a hospital.ConclusionsQuerying patients directly on their toxicity and related treatment experience was highly feasible. Notable variation in reported toxicities occurred across practices and enabled them to act on their own data. Toxicity severity and related service use exceeded the incidence reported in clinical trials.Implications for Policy or PracticeSoliciting patient‐reported outcomes from patients outside of clinical trials can inform the clinical community on the patient experience and motivate clinical practice changes. Adults treated for invasive cancer continue to report persistent challenges in managing pain, fatigue, and gastrointestinal issues. Providing patients with open‐text sections enabled the study team to explore toxicities emerging from newer treatment regimens.Primary Funding SourceAgency for Healthcare Research and Quality.

Preliminary study of PD-1 inhibitor in the treatment of drug-resistant recurrent gestational trophoblastic neoplasia

Objective: To investigate the therapeutic effect of programmed cell death receptor 1 (PD-1) inhibitor in drug-resistant recurrent gestational trophoblastic neoplasia (GTN). Methods: Clinicopathological features, previous treatments, PD-1 inhibitor treatment and prognosis of 8 patients with drug-resistant recurrent GTN treated with PD-1 inhibitor pembrolizumab， in Peking Union Medical College Hospital of Chinese Academy of Medical Sciences from August 2018 to June 2019 were collected and retrospectively analyzed. Results: (1) Clinicopathological features: the average age of onset of 8 GTN patients was 32.9 years old (31-39 years old); pathological types: choriocarcinoma in 7 cases, epithelioid trophoblastic tumor in 1 case. International Federation of Gynecology and Obstetrics (FIGO) stages: stage Ⅲ in 5 cases, stage Ⅳ in 3 cases; FIGO score: 4 patients with 7-12 points (high-risk group) and 4 patients with ≥13 points (ultra high-risk group). All the 8 patients had lung metastasis, 2 patients with brain metastasis, 1 patient with kidney and 1 patient with intestinal metastasis. (2) Previous treatments: ① Chemotherapy: 8 patients with GTN received an average of 21.1 courses (5-30 courses) of chemotherapy; the main route was systemic intravenous chemotherapy. One patient received intrathecal methotrexate chemotherapy due to brain metastasis. ② Surgery: 7 of 8 patients with GTN received surgical treatment, including 5 cases of pelvic surgury, 6 cases of pulmonary lobectomy and 1 case of right hemicolectomy. ③ Radiotherapy: 2 of 8 patients with GTN received radiotherapy, among which 1 patient received radiotherapy for lung for 8 times due to lung metastasis, and the other one received radiotherapy for lung, right sacroiliac joint and skull for a total of 22 times. (3) PD-1 inhibitor treatment: 8 patients with GTN received PD-1 inhibitor treatment with a mean course of 9 (2-12 courses). Six patients appeared Ⅰ-Ⅱ grade of immune related adverse events (AE), and no severe AE occurred. (4) Prognosis: after 2-3 courses of PD-1 inhibitor treatment, serum β-hCG level came to normalization in 4 patients. They were followed up for 2-7 months without any recurrence after 0-9 courses of consolidation treatment. One patient received 12 courses of PD-1 inhibitor treatment. The serum β-hCG level normalized after the 6th courses but increased 1 months later, and then received bevacizumab treatment due to the progression of the disease. The remaining 3 patients received other chemotherapy regiments due to disease progression during PD-1 inhibitor treatment. Conclusions: PD-1 could be used as a remedial treatment for drug-resistant recurrent GTN, with a high effective rate and relatively mild AE. However, more cases need to be accumulated clinically and efficacy should be comprehensively evaluated in combination with pathology and immunohistochemical examination.

Pressurized intra peritoneal aerosol chemotherapy (PIPAC) vs. intravenous chemotherapy to assess quality of life &amp; response rates in unresectable peritoneal metastases secondary to platinum resistant ovarian cancer: A comparative study.

e18091 Background: The primary objective of this study is to assess Qol &amp; response rates in platinum resistant ovarian cancer patients with peritoneal metastasis treated with PIPAC procedure in comparison with conventional systemic intravenous chemotherapy. Methods: Between October 2017 and December 2019, 31 PIPAC applications were done in 15 patients with cisplatin 10.5mg/m2 and doxorubicin 2.1mg/m2. During same period 20 patients received systemic chemotherapy with clinician’s choice of drug ((mono-therapy consisting of pegylated liposomal doxorubicin or topotecan or gemcitabine or paclitaxel weekly with or without bevacizumab).The response rate (With MRI &amp; Ca-125) &amp; quality of life assessment (QLQ C-30) of both the group was done periodically and recorded. Results: Overall 35 patients were analysed in this study. The results have been presented in Table. Conclusions: PIPAC in comparison to intravenous chemotherapy for platinum resistant ovarian cancer with peritoneal metastasis showed better response rates (66.6 vs. 22.4%) and improved quality of life score. PIPAC has shown promising results and should be in the arsenal of the clinicians managing patients with platinum resistant ovarian cancer. [Table: see text]

Poor perfusion of the microvasculature in peritoneal metastases of ovarian cancer

Most women with epithelial ovarian cancer (EOC) suffer from peritoneal carcinomatosis upon first clinical presentation. Extensive peritoneal carcinomatosis has a poor prognosis and its pathophysiology is not well understood. Although treatment with systemic intravenous chemotherapy is often initially successful, peritoneal recurrences occur regularly. We hypothesized that insufficient or poorly-perfused microvasculature may impair the therapeutic efficacy of systemic intravenous chemotherapy but may also limit expansive and invasive growth characteristic of peritoneal EOC metastases. In 23 patients with advanced EOC or suspicion thereof, we determined the angioarchitecture and perfusion of the microvasculature in peritoneum and in peritoneal metastases using incident dark field (IDF) imaging. Additionally, we performed immunohistochemical analysis and 3-dimensional (3D) whole tumor imaging using light sheet fluorescence microscopy of IDF-imaged tissue sites. In all metastases, microvasculature was present but the angioarchitecture was chaotic and the vessel density and perfusion of vessels was significantly lower than in unaffected peritoneum. Immunohistochemical analysis showed expression of vascular endothelial growth factor and hypoxia inducible factor 1α, and 3D imaging demonstrated vascular continuity between metastases and the vascular network of the peritoneum beneath the elastic lamina of the peritoneum. We conclude that perfusion of the microvasculature within metastases is limited, which may cause hypoxia, affect the behavior of EOC metastases on the peritoneum and limit the response of EOC metastases to systemic treatment.

The efficacy and feasibility of adopting intravenous chemotherapy and oral S-1 as a sequential therapy for postoperative gastric cancer patients.

Some postoperative gastric cancer patients have to terminate systemic intravenous chemotherapy early due to adverse drug reactions. We performed a retrospective study to explore the efficacy and feasibility of sequential therapy.We retrospectively analyzed 55 postoperative gastric cancer patients (Group A) who received sequential therapy (intravenous chemotherapy and S-1) and 53 patients (Group B) who received intravenous chemotherapy from January 2012 to December 2013 in our hospital. The therapeutic effect (including 1-year, 5-year tumor recurrence and survival rate) and the incidence of adverse reactions were analyzed.When death and survival for more than 5 years was regarded as the end point of follow-up, the mean follow-up period was 40.6 months (34.7–46.4) in Group A and 39.2 months (33.0–45.3) in Group B. The 1-year tumor recurrence after the operation was 23.6% (13/55, Group A) and 28.3% (15/53, Group B). The 5-year tumor recurrence was 45.5% (25/55, Group A) and 49.1% (26/53, Group B). There was no significant difference in the 1- and 5-year tumor recurrence rates between these two groups (P > .05). The 1-year survival rates of Group A and Group B were 81.8% (45/55) and 79.2% (42/53), respectively, and the 5-year survival rates of Group A and Group B were 47.3% (26/55) and 45.3% (24/53), respectively. No significant difference was observed between these two treatments at either the 1- or 5-year survival benefit (P > .05). However, the patients in Group A had a lower incidence of gastrointestinal reactions (such as nausea and vomiting), leukopenia and liver function damage (P < .05). We also found that patients who underwent sequential therapy might show lower levels of adverse reactions.Our retrospective study provided some evidence to suggest that sequential treatment is effective and safe for postoperative gastric cancer patients who are intolerant to intravenous chemotherapy.

Clinical efficacy of Da Vinci robot-assisted radical resection for right colon cancer

Objective To investigate the clinical efficacy of Da Vinci robot-assisted radical resection for right colon cancer. Methods The retrospective cross-sectional study was conducted. The clinical data of 85 patients with right colon cancer who were admitted to the First Hospital Affiliated to Army Medical University from August 2013 to February 2019 were collected. There were 56 males and 29 females, aged from 29 to 84 years, with an average age of 60 years. All patients underwent Da Vinci robot-assisted radical resection of right colon cancer, named right hemicolon D3 + complete mesocolic excision, and received infection prevention and total parenteral nutrition treatment after surgery. According to clinical pathological staging of guideline issued by National Comprehensive Cancer Network, patients underwent postoperative chemotherapy within 1 year after surgery. Observation indicators: (1) treatment status; (2) postoperative pathological examination; (3) follow-up. Follow-up was conducted using outpatient examination, telephone interview and mail every 3 months within 1 year after surgery, every 6 months from 1 to 3 years after surgery, and once a year from 3 to 5 years after surgery up to March 2019. The postoperative tumor metastasis and survival of patients were obtained. Measurement data with normal distribution were represented as Mean±SD, and measurement data with skewed distribution were described as M (range). Count data were expressed as absolute number. Survival rates were calculated using life-table method. Results (1) Treatment status: 85 patients underwent Da Vinci robot-assisted right hemicolon D3 + complete mesocolic excision successfully. The operation time, volume of intraoperative blood loss, time for postoperative out-of-bed activities, time to recovery of gastrointestinal function, time to liquid diet intake were (178±28)minutes, (85±33)mL, (2.9±1.8)days, (3.1± 2.7)days, (3.9±1.9)days, respectively. There was no perioperative death. Eleven patients had postoperative complications including 5 of anastomotic leakage, 2 of anastomotic bleeding, 2 of pulmonary infection, 1 of gastric emptying disorder and 1 of incomplete intestinal obstruction; they were cured and discharged after conservative treatment. All the 85 patients received postoperative infection prevention and total parenteral nutrition support, including 64 receiving systemic intravenous chemotherapy with 6-8 cycles of FOLFOX or XELOX, 7 receiving 6-8 cycles of oral capecitabine, and 14 receiving no chemotherapy. (2) Postoperative pathological examination: the number of harvested lymph nodes was 20±11 and 25 had lymph node metastasis. The length of proximal and distal cutting edge of the specimens was (16±5)cm and (9±5)cm, respectively. There was no cancerous cell on the cutting edge. High-differentiated adenocarcinoma, moderate-differentiated adenocarcinoma, moderate-differentiated tubular adenocarcinoma, low-differentiated adenocarcinoma, mucinous adenocarcinoma, tubular combined with mucinous adenocarcinoma were detected in 2, 40, 14, 16, 9, 4 patients, respectively. There were 8, 28, 24, 5, 12, 8 patients inⅠstage, ⅡA stage, ⅡB stage, ⅡC stage, ⅢB stage, ⅢC stage of TNM staging, respectively. (3) Follow-up: 85 patients were followed up for 1-67 months, with a median follow-up time of 19 months. During the follow-up, 1 of 85 patients had liver metastasis at 14 months after surgery and had survived after radiofrequency ablation treatment up to the end of follow-up. Three cases died of abdominal tumor metastases, 1 of which inⅡC stage died at 32 months after surgery, 1 in ⅢB stage died at 4 months after surgery and 1 in ⅢB stage died at 16 months after surgery. The 1-, 3-year overall survival rates were 97.1% and 94.0%, respectively. Conclusion Da Vinci robot-assisted radical resection of right colon cancer is safe and feasible, with good short- and long-term outcomes. Key words: Colon neoplasms; Right colon cancer; Right hemicolectomy; Da Vinci robotic surgical system; Prognosis

Pressurized IntraPeritoneal Aerosol Chemotherapy vs. intravenous chemotherapy for unresectable peritoneal metastases secondary to platinum resistant ovarian cancer - study protocol for a randomized control trial.

BackgroundDespite optimal surgery and appropriate first-line chemotherapy, ∼70–80 % of patients with epithelial ovarian cancer will develop disease relapse. The prognosis is poor especially for women with Platinum resistant ovarian cancer. The standard treatment for these groups of patients is non-platinum-containing chemotherapy like taxanes, anthracyclines, gemcitabine, topotecan, and trabectedin. These drugs in various combinations and sequences provide modest survival or symptomatic benefit but with significant side effects. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) is a minimally-invasive drug-delivery technique specifically addressing limited tissue penetration and poor drug distribution with promising results. PIPAC is a novel method of delivering normothermic chemotherapy into the abdominal cavity as an aerosol under pressure. This concept seems to enhance the effectiveness of intra peritoneal chemotherapy by taking advantage of the physical properties of gas and pressure by generating an artificial pressure gradient and enhancing tissue uptake and distributing drugs homogeneously within the closed and expanded peritoneal cavity. Thus, due to the high local bioavailability during PIPAC, the chemotherapy dosage can be reduced which in turn largely prevents systemic side effects and organ toxicity.MethodsThe study aims to investigate the therapeutic efficacy measured as objective tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria, of PIPAC in comparison with conventional Intravenous chemotherapy for women with recurrent platinum resistant ovarian cancer with peritoneal metastasis (PM). Consecutive patients diagnosed with PM secondary to platinum-resistant ovarian cancer will be randomized to PIPAC group or IV chemotherapy group. The primary objective of this study is to determine the efficacy after three cycles of PIPAC with cisplatin and doxorubicin in comparison with six cycles of systemic chemotherapy. The secondary outcome measures include morbidity and mortality, overall survival and disease specific survival. Analysis is by intention to treat.AimAssess the objective tumour response of PIPAC in comparison with systemic intravenous chemotherapy for women with platinum-resistant ovarian cancer.Study typeProspective randomized control intervention trial.Intervention modelIV Chemotherapy group (Control group) PIPAC group (Experimental group)MaskingOpen label.Primary purposeTreatment.Sample sizeCalculated sample size is 97 and rounded to 100. For each treatment group sample size of 50 will be considered.Primary outcome criteriaObjective tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1.Secondary outcome criteriaMorbidity;Disease-specific survival (months between inclusion and death due to ovarian cancer);OS (months between inclusion and death due to any cause);CA 125 levels.DiscussionPIPAC in women with platinum resistant ovarian PM has good response owing to superior tissue penetration and better drug distribution. The procedure is safe and well tolerated owing it to its minimal invasiveness. Typical side-effects of systemic chemotherapy, such as alopecia, peripheral neurotoxicity, nausea and myelosuppression are absent. We expect reduction of ascites with symptomatic relief and CA 125 levels. PIPAC is a novel technique for selected patients with platinum resistant ovarian PM and further investigation in comparative clinical trials with conventional chemotherapy will establish its role as a good palliative treatment option.Ethics committee approvalObtained.StatusRecruiting.Trial registration numberREF/2018/08/021223 Registered on Clinical Trials Registry – India (CTRI); www.ctri.nic.in