Complete Control Rate Research Articles

Radiological patterns of tumour progression in patients treated with a combination of immune checkpoint blockers and antiangiogenic drugs

BackgroundImmune checkpoint blockers (ICBs) in combination with antiangiogenic drugs showed synergistic efficacy in several tumour types. New patterns of progression have recently been defined upon treatment with ICB alone including atypical responses such as pseudoprogression (PsPD), dissociated response and hyperprogressive disease (HPD). This study aimed to describe the patterns of response observed in patients treated with combination ICB with antiangiogenic drugs. MethodsWe conducted a monocentric retrospective analysis of patients (pts) enrolled in phase I trials at Gustave Roussy assessing the combination of ICB and antiangiogenic drugs. Radiological CT scans were centrally reviewed by a senior radiologist according to iRECIST criteria including progressive disease (PD), partial response (PR) and stable disease (SD). HPD was defined as a progression at the first evaluation with a delta tumour growth rate exceeding 50%. PsPD was defined as initial progression followed by stabilisation or decrease of tumour size, DisR as a concomitant size decrease in some tumour lesions and size increase in others. Both PsPD and DisR are defined as atypical responses. Overall response rate included PR and complete response (CR) and disease control rate included PR, CR and SD. ResultsBetween December 2016 and June 2020, 111 pts were included. The median follow up was 12.8 months (11.3–15.1). The most common tumour types were lung and pleura (20%), kidney (18%) and bladder (17%). The overall response rate and disease control rate were 21.6% (n = 24) and 59% (n = 65), respectively. Twenty-one patients (19%) experienced PD as the best response. PsPD, DisR and HPD were observed in 4 (3.6%), 11 (9.9%) and 7 (6.3%) pts, respectively. DisR and PsPD were associated with longer iProgression Free Survival (median: 6.9 and 18.9 months, respectively) and iOverall Survival (median: 28.4 and 31.1 months, respectively) than a median of SD in immune progression-free survival (median: 4.2 months) and immune overall survival (median: 12.7 months). ConclusionPatients treated with ICBs and antiangiogenic agents display atypical responses. Survival might be longer in patients with DisR responses and PsPD disease than patients with HPD, PD and SD.

A meta-analysis of the long-term outcomes following surgery or endoscopic therapy for chronic pancreatitis

PurposeRefractory abdominal pain is a cardinal symptom of chronic pancreatitis (CP). Management strategies revolve around pain mitigation and resolution. Emerging evidence from observational studies highlights that surgery may result in superior pain relief when compared to endoscopic therapy; however, its impact on long-term quality of life or functional outcome has yet to be determined.MethodsA search through MEDLINE, PubMed and Web of Science was performed for RCTs that compared endoscopic treatment with surgery for the management of CP. The main outcome measure was the impact on pain control. Secondary outcome measures were the effect on quality of life and the incidence rate of new onset exocrine and endocrine failure. Data was pooled for analysis using either an odds ratio (OR) or mean difference (MD) with a random effects model.ResultsThree RCTs were included with a total of 267 patients. Meta-analysis demonstrated that operative treatment was associated with a significantly higher rate of complete pain control (37%) when compared to endoscopic therapy (17%) [OR (95% confidence interval (CI)) 2.79 (1.53–5.08), p = 0.0008]. No difference was noted in the incidence of new onset endocrine or exocrine failure between treatment strategies.ConclusionSurgical management of CP results in a greater extent of complete pain relief during long-term follow-up. Further research is required to evaluate the impact of the time interval between diagnosis and intervention on exocrine function, combined with the effect of early up-front islet auto-transplantation in order to determine whether long-term endocrine function can be achieved.

Oligometastatic Rectal Adenocarcinoma Treated With Short-Course Radiotherapy and Chemotherapy with Non-Operative Intent of the Primary for Pelvic Complete Responders

Sequential short-course radiotherapy and chemotherapy (SCRT-CH) is a promising treatment for non-operative management of rectal adenocarcinoma. This paradigm has not been evaluated for newly diagnosed oligometastatic (OM1) patients (pts). We evaluated rates of locoregional clinical complete response (cCR), rectal surgeries, and local control (LC) in newly diagnosed OM1 pts treated with definitive treatment of the primary tumor with SCRT-CH with non-operative intent for pts with locoregional cCR.From 2/2018 to 5/2020, 39 pts with newly diagnosed OM1 rectal cancer were treated with SCRT-CH and non-operative intent for locoregional cCR at a single institution. OM1 disease was considered disease confined to ≤ 2 distant sites. Pts received 25 Gy/5 fx to the pelvis with an optional boost to 35 Gy for involved extra-mesorectal lymph nodes. CH was delivered prior to and/or after RT. Locoregional cCR was assessed via DRE, sigmoidoscopy, and/or pelvic MRI following completion of SCRT-CH. Follow-up was calculated from RT completion. Survival was evaluated by Kaplan-Meier method and log rank test.All 39 pts with 47 distant sites completed SCRT and 36 (92%) had CH. 22 (56%) received all CH following RT, and 24 (62%) received at least 2 months of CH after RT. 33 pts received 1st line FOLFOX +/- bevacizumab (bev). 13 pts underwent low anterior resection and 2 pts underwent abdominoperineal resection. 19 pts had 23 distant sites treated. The most common distant site treated was liver and the most common modality was resection. Following SCRT, only 4 pts (10%) experienced a local failure (median 6.4 months, range 0.7-10.7 months). 6/39 experienced a pelvic cCR (15%); all cCR pts received SCRT first followed by at least 2 months of CH. Pts with a cCR were more likely to have received at least 2 months of CH following SCRT compared to patients without a cCR (100% vs. 59%, P < .05). The median follow-up for living pts was 16 months. The 1-year overall survival (OS) was 66% (95% CI: 51-84%) for all pts. Pts who received at least 2 months of CH following SCRT had an improved OS (1-year OS [95% CI]: 82% [68-100%] vs. 29% [10-84%], P < .001 by log-rank) compared to pts who did not.SCRT-CH with non-operative intent for pts in locoregional cCR is a promising treatment paradigm for OM1 rectal cancer pts.

Phase II study of definitive chemoradiation for locally advanced squamous cell cancer of the vulva: An efficacy study

ObjectiveTo evaluate feasibility of chemoradiation as alternative for extensive surgery in patients with locally advanced vulvar cancer and to report on locoregional control, toxicity and survival. MethodsIn a multicenter, prospective phase II trial patients with locally advanced vulvar cancer were treated with locoregional radiotherapy combined with sensitizing chemotherapy (capecitabine). Treatment feasibility, percentage locoregional control, survival and toxicity were evaluated. Results52 patients with mainly T2/T3 disease were treated according to the study protocol in 10 centers in the Netherlands from 2007 to 2019. Full dose radiotherapy (tumor dose of 64.8Gy) was delivered in 92% and full dose capecitabine in 69% of patients. Most prevalent acute ≥ grade 3 toxicities were regarding skin/mucosa and pain (54% and 37%). Late ≥grade 3 toxicity was reported for skin/mucosa (10%), fibrosis (4%), GI incontinence (4%) and stress fracture or osteoradionecrosis (4%). Twelve weeks after treatment, local clinical complete response (cCR) and regional control (RC) rates were 62% and 75%, respectively. After 2 years, local cCR persisted in 22 patients (42%) and RC was 58%. Thirty patients (58%) had no evidence of disease at end of follow-up (median 35 months). In 9 patients (17%) extensive surgery with stoma formation was needed. Progression free survival was 58%, 51% and 45% and overall survival was 76%, 66%, 52% at 1,2, and 5 years. ConclusionsDefinitive capecitabine-based chemoradiation as alternative for extensive surgery is feasible in locally advanced vulvar cancer and results in considerable locoregional control with acceptable survival rates with manageable acute and late toxicity.

Efficacy and safety of 5\u2009mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials

BackgroundThe efficacy of olanzapine as an antiemetic agent in cancer chemotherapy has been demonstrated. However, few high-quality reports are available on the evaluation of olanzapine’s efficacy and safety at a low dose of 5 mg among patients treated with carboplatin regimens. Therefore, in this study, we investigated the efficacy and safety of 5 mg olanzapine for managing nausea and vomiting in cancer patients receiving carboplatin regimens and identified patient-related risk factors for carboplatin regimen-induced nausea and vomiting treated with 5 mg olanzapine.MethodsData were pooled for 140 patients from three multicenter, prospective, single-arm, open-label phase II studies evaluating the efficacy and safety of olanzapine for managing nausea and vomiting induced by carboplatin-based chemotherapy. Multivariable logistic regression analyses were performed to determine the patient-related risk factors.ResultsRegarding the endpoints of carboplatin regimen-induced nausea and vomiting control, the complete response, complete control, and total control rates during the overall study period were 87.9, 86.4, and 72.9%, respectively. No treatment-related adverse events of grade 3 or higher were observed. The multivariable logistic regression models revealed that only younger age was significantly associated with an increased risk of non-total control. Surprisingly, there was no significant difference in CINV control between the patients treated with or without neurokinin-1 receptor antagonist.ConclusionsThe findings suggest that antiemetic regimens containing low-dose (5 mg) olanzapine could be effective and safe for patients receiving carboplatin-based chemotherapy.

Clinical Observation of Gene Polymorphism of Olanzapine or Aprepitant in Prevention of CINV.

ObjectiveThe present study aims to investigate the correlation between the gene polymorphisms of the multidrug resistance protein 1 (ABCB1), the intron region of transcriptional factor (GTF2E1) and catechol-O-methyltransferase (COMT), dopamine receptor (DRD2), and the control of chemotherapy-induced nausea and vomiting (CINV) by olanzapine or aprepitant in a Chinese population under a fractionated cisplatin dosing pattern.MethodsAntiemetic treatment with 5 mg of olanzapine or aprepitant triplet therapy was conducted in 210 patients with malignancies receiving cisplatin multi-day chemotherapy. The general data on the patients were collected with the evaluation of the rate of complete protection (TP), complete remission (CR), complete control (TC), and time to first vomiting, the functional living index-emesis (FLIE) scale, and side effects in the acute and delayed phases. The DNA mass spectrometry detected the gene polymorphisms of ABCB1, GTF2E1, COMT, and DRD2, and the correlation with TP was analyzed.Results1) There were no statistically significant differences in the TP, CR, TC, time of first vomiting, and FLIE index at different phases between the 5mg of olanzapine group and the aprepitant group (P > 0.05). 2) The main side effect in the olanzapine group was drowsiness (P = 0.00), and in the aprepitant group was constipation (P = 0.02). 3) The distributions of each genotype were in the Hardy–Weinberg (H–W) equilibrium. Univariate analysis showed that in the olanzapine group, delayed-phase TP was correlated with the ABCB1 rs1045642 non-TT (P = 0.01) genotype.ConclusionThe present study revealed that females and the rs1045642TT genotype were independent risk factors for delayed-phase CINV in the northern Chinese population, which provided a scientific basis for subsequent CINV-related analysis of high-risk factors in Chinese patients.

Comparison of open and intracorporeal modified ureterosigmoidostomy (Mainz II) after laparoscopic radical cystectomy with bladder cancer

ObjectiveTo compare perioperative and oncologic outcomes of open modified ureterosigmoidostomy urinary diversion (OMUUD) and intracorporeal modified ureterosigmoidostomy urinary diversion (IMUUD) following laparoscopic radical cystectomy (LRC).Patients and methodsWe retrospectively reviewed our single institutional collected database patients undergoing LRC from October 2011 to October 2019. The perioperative characteristics were compared between OMUUD and IMUUD, and overall survival (OS) and progression-free survival (PFS) were evaluated by the Kaplan-Meier method.ResultsOverall, 84 patients were included. OMUUD and IMUUD were performed in 63 (75%) and 21 (25%) patients, respectively. IMUUD patients demonstrated shorter postoperative length of stay (16.24 ± 3.91 days vs. 18.98 ± 7.41 days, P = 0.033), similar operation time (498.57 ± 121.44 vs. 462.24 ± 99.71, P = 0.175), similar estimated blood loss [400 (200–475) ml vs. 400 (200–700) ml, P = 0.095], and similar overall complication rate within 30 days (19.05% vs. 25.40%, P = 0.848) and 90 days (23.81% vs. 17.46%, P = 0.748). Complete urinary control rate was 87.3% (55/63) in the OMUUD group. In IMUUD, the complete urinary control rate was 90.5% (19/21). There was no significant difference in OS (χ2 = 0.015, P = 0.901) and PFS (χ2 = 0.107, P = 0.743) between the two groups.ConclusionIMUUD postoperative recovery is faster; other perioperative outcomes and oncology results are not significantly different with OMUUD. It is indicated that IMUUD can be utilized safely and effectively in the urinary diversion after LRC.

Incidence of chemotherapy-induced nausea and vomiting among cancer patients receiving moderately to highly emetogenic chemotherapy in cancer centers in Sichuan, China.

Nausea and vomiting are the most painful and feared side effects for patients during chemotherapy. Currently, most studies focus on the occurrence of CINV during the risk phase. We initiated this real-world study to understand the actual occurrence of CINV throughout all phases, to provide a basis to prevent CINV in patients during chemotherapy and improve their quality of life. This prospective real-world study was conducted at 17 major cancer centers in Sichuan, China. Cancer patients who were about to receive moderately/highly emetogenic chemotherapy were included in the study. Occurrences of nausea and vomiting were recorded using patient diaries, and physicians are responsible for recording patient clinical data. A total of 1,139 patients were included in this study between August 2018 and April 2019. In this study, the incidence of acute CINV was 55.3%, delayed CINV was 62.3%, and CINV beyond the risk period was 36%. All phases overall, the overall complete control (CC) rate of CINV was 30.1 and 32.1% for highly and moderately emetogenic chemotherapy regimens, respectively. The median CC time for CINV was 7days, but only 21.5% of these patients used antiemetic regimens according to the NCCN guideline. In the real world, the incidence of CINV is high in patients receiving chemotherapy, and nausea and vomiting may occur beyond the risk period; the low level of standardized antiemetic treatment in compliance with the guideline might have been the main reason for unsatisfactory prevention and control of CINV in this study.

Long-term efficacy of triple semicircular canal plugging in the treatment of patients with ipsilateral delayed endolymphatic hydrops

This study aims to explore the long-term efficacy of triple semicircular canal plugging (TSCP) in the treatment of intractable ipsilateral delayed endolymphatic hydrops (DEH), so as to provide an alternative therapy for this disease. Forty-eight patients diagnosed with ipsilateral DEH referred to vertigo clinic of our hospital between Dec. 2010 and Dec. 2017, were included in this study for retrospective analysis. All patients were followed up for 2 years. Vertigo control and auditory functions were measured and analyzed. Pure tone audiometry, caloric test, and vestibular evoked myogenic potential (VEMP) were performed in two-year follow-up. Forty-five patients who accepted intratympanic gentamicin (26.7 mg/mL) twice given one week apart were selected as a control group. The total control rate of vertigo in TSCP group was 97.9% (47/48) in the two-year follow-up, with complete control rate of 83.3% (40/48) and substantial control rate of 14.6% (7/48). The rate of hearing loss was 22.9% (11/48). The total control rate of vertigo in intratympanic gentamicin group was 80.0% (36/45), with complete control rate of 57.8% (26/45) and substantial control rate of 22.2% (10/45), and the rate of hearing loss was 20.0% (9/45). The vertigo control rate of TSCP was significantly higher than that of intratympanic gentamicin (χ2 = 6.01, p < 0.05). There was no significant difference of hearing loss rate between two groups. (χ2 = 0.12, p > 0.05). TSCP, which can reduce vertiginous symptoms in patients with intractable ipsilateral DEH, represents an effective therapy for this disorder.

Outcomes of older adults aged 90 and over with cutaneous malignancies after electrochemotherapy with bleomycin: A matched cohort analysis from the InspECT registry

BackgroundWith extending life expectancy, more people are diagnosed with cutaneous malignancies at advanced ages and are offered nonsurgical treatment. We assessed outcomes of the oldest-old adults after electrochemotherapy (ECT). MethodsThe International Network for Sharing Practices of ECT (InspECT) registry was queried for adults aged ≥90 years (ys) with skin cancers/cutaneous metastases of any histotype who underwent bleomycin-ECT (2006–2019). These were subanalysed with patients aged <90 ys after matching 1:2 for tumor location, number, size, histotype, and previous treatments. We assessed ECT modalities, toxicity (CTCAE), response (RECIST), and patient perception (EQ-5D). ResultsSixty-one patients represented the study cohort (median 92 ys, range 92–104), 122 the control group (median 77 ys, range 23–89). Among the oldest-old, 44 patients (72%) had primary/recurrent skin cancers, 17 (28%) cutaneous metastases. Median tumour size was 15 mm (range, 5–450). The oldest-old adults underwent ECT mainly under local/regional anaesthesia (59% vs 39% p = .012). We observed no differences regarding dose and route of chemotherapy (intravenous vs intratumoral, p = .308), electrode geometry (linear vs hexagonal, p = .172) and procedural duration (18 vs 21 min, p = .378). Complete response (57.4 [95%-CI 44.1%–70.0%] vs 64.7% [95%-CI 55.6%–73.2%], p = .222) and 1-year local control (76.7% vs 81.7, p = .092) rates were comparable. Pain and skin hyperpigmentation were mild in both groups. Skin ulceration persisted longer in the oldest-old patients (4.4 vs 2.4 months, p = .008). ConclusionsThe oldest-old adults with cutaneous malignancies undergo ECT most commonly under local/regional anaesthesia with safety profiles and clinical effectiveness similar to their younger counterparts, except in case of ulcerated tumors.

Low Dose Intratympanic Gentamicin in Ménière's Disease.

Intratympanic gentamicin has become an accepted standard of care for Ménière's disease. But there still exists controversies regarding the dosing protocol as well as the drug concentration for optimum control of vertigo and hearing preservation. To determine if 20mg of intratympanic gentamicin administered once a month for a maximum of 2months can alleviate intractable vertigo caused by definite Ménière's disease with hearing preservation. Once diagnosed with definite Ménière's disease as per AAO-HNS criteria, the patient was given 0.5ml of 40mg/ml intratympanic gentamicin. Follow-up was done at 1-month and 6-month post-treatment. If at 1-month review patient continued to have vertigo one more dose of intratympanic gentamicin was administered. Thirty-two patients were included in the study. Seventeen patients (53.1%) received one dose and 15 patients (46.9%) received two doses of intratympanic injection. We achieved an effective vertigo control of 59.4% and complete vertigo control rate of 53.1%. Worsening of symptoms was noted in 1 patient. Hearing was preserved in all patients except for one. Among the patients who attained effective vertigo control, 72.2% had dead labyrinth at 6-month cold caloric status. A single injection of 20mg intratympanic gentamicin can alleviate intractable vertigo caused by definite Ménière's disease with hearing preservation. Non-responders may be given a second dose after one month. Intratympanic gentamicin is a simple, cheap treatment that can be carried out in an out-patient setting.

PDG5 Cost- Effectiveness Analysis between Aprepitant and Fosaprepitant in the Prevention of Chemotherapy-Induced Nausea and Vomiting in China

The one of important goals for cancer patients receiving chemotherapy is to prevent the chemotherapy-induced nausea and vomiting (CINV) cost-effectively. Although some medicines are effective in preventing CINV, the drug expenditures raises concern regarding incremental financial burden of patients. Our purpose is to evaluate the cost-effectiveness of aprepitant (APR)- and fosaprepitant (FosAPR)-containing regimens for the prevention of CINV among patients receiving high emetogenic chemotherapy from the Chinese payer perspective. A decision tree model was established to measure the five-day costs and health outcomes between APR-containing regimen ( aprepitant, palonosetron and dexamethasone) and FosAPR-containing regimen (fosaprepitant, palonosetron and dexamethasone). Clinical data was derived from a randomized, double-blind controlled trail on Chinese inpatients who received high emetogenic chemotherapy. All medical costs were calculated in RMB from the perspective of Chinese health system. Quality-adjusted life-years (QALYs) were used to estimate the utility outcomes and the incremental cost-effectiveness ratio (ICER) was calculated to assess the economics of FosAPR. One-way sensitivity analysis and probabilistic sensitivity analysis were conducted to test the robustness of the model. Compared with APR, FosAPR had a mean health-care savings of ￥121.56 but had 0.0001815 QALY less than APR, resulting in ICER of ￥669926.19 per QALY. One-way sensitivity analysis revealed that the cost of APR was the most influential factor to the ICER. The cost of FosAPR and the complete control rate of delayed period also had a high impact on the results. According to the probabilistic analysis, the acceptability of FosAPR was more than 80% when the Chinese willingness-to-pay (WTP) was ￥198,018. FosAPR had the same treatment effect with APR but was cost-effective in China at the current WTP threshold. Only if the threshold went to more than ￥600,000,aprepitant might be cost-effective.

Risk factors of chemotherapy-induced nausea and vomiting in patients with metastatic colorectal cancer: a prospective cohort study (YCOG1301).

Although the effectiveness of antiemetic therapy for colorectal cancer chemotherapy has improved with further drug development, some patients still suffer from chemotherapy-induced nausea and vomiting (CINV) even with only 5-hydroxytryptamine-3 receptor antagonist and dexamethasone. The present study investigated the risk factors of CINV in patients who received chemotherapy for colorectal cancer and clarified which patients need additional neurokinin 1 receptor antagonist. Patients with colorectal cancer receiving moderate-emetic-risk chemotherapy (MEC) were enrolled in this prospective single-arm study with intravenous palonosetron 0.75 mg and dexamethasone 9.9 mg before chemotherapy and with paroral dexamethasone 8 mg on days 2 and 3. The primary endpoint was the complete response (CR) rate for delayed-phase CINV. A total of 179 patients were eligible for this study. The delayed CR rate was 84.9% (152/179). There were no significant differences in any risk factors, but women with a low body mass index (BMI) (a combination of "female sex" and "BMI < 20") showed a significantly lower rate of CC (complete control) (odds ratio [OR] = 0.45, 95% confidence interval [CI] = 0.17-1.13; p = 0.039), and young patients with a low BMI (combination of "age < 65" and "BMI < 20") showed a significantly lower rate of CR (OR = 0.34, 95% CI = 0.13-0.88; p = 0.022) than the other patients. This study failed to identify any single risk factors associated with delayed CINV in patients who received chemotherapy for advanced colorectal cancer. However, combinations of "thin and women" or "young and thin patients" might be possible predictive conditions, thus, candidates for NK1 receptor antagonist administration in MEC. Further investigations are required to develop criteria for the supplementation of NK1 receptor antagonist.

Granisetron transdermal system and dexamethasone for the prevention of nausea and vomiting in multiple myeloma patients receiving chemo-mobilization: An observational real-world study of effectiveness and safety

PURPOSECyclophosphamide (CY) in a dose of 2–4 g/m2 is widely used for hemopoietic progenitor stem cells mobilization. CY administration is associated with several adverse effects, including chemotherapy-induced nausea and vomiting (CINV). This study aimed to evaluate the efficacy and tolerability of granisetron transdermal system (GTDS) plus dexamethasone in the management of CINV in MM patients undergoing chemo-mobilization with CY. METHODSIn this single-center, prospective, observational, real world study, GTDS plus dexamethasone was administered to MM patients receiving chemo-mobilization based on CY 2 g/m2 plus G-CSF in an outpatient setting. The rate of complete response was evaluated as the main outcome. Other outcomes were rate of complete control of CINV, incidence of nausea/vomiting of any grade and safety. RESULTSA total of 88 patients were enrolled. A complete response was achieved in 45.5 % of patients; among them, 39.77 % attained complete control of CINV. Nausea and vomiting never occurred in 34.1 % and 45.5 % of patients, respectively. No episodes of grade 3–4 nausea and/or vomiting were documented. GTDS was safe and well tolerated. CONCLUSIONIn real world, GTDS provided an innovative, effective, and well-tolerated control of CINV in MM patients after chemo-mobilization with CY. The study found out effectiveness of a non-invasive delivery system of antiemetic.

Efficacy of Olanzapine-Triple Antiemetic Regimen in Patients with Gastrointestinal Tumor and High Risk of Chemotherapy-Induced Nausea and Vomiting Receiving Moderately Emetogenic Chemotherapy: A Retrospective Study.

PurposeDexamethasone combined with 5-hydroxytryptamine type 3 receptor antagonists (5-HT3 RA) dual regimen is the standard prophylaxis regimen for patients receiving moderately emetogenic chemotherapy (MEC). However, it has been found in real-world practice that chemotherapy-induced nausea and vomiting (CINV) remains poorly controlled among patients with gastrointestinal tumor, especially in those with high-risk factors for vomiting, such as female, young, and non-alcoholic individuals. Hence, we aimed to evaluate the efficacy of an olanzapine-containing triple regimen in this clinical setting.Patients and MethodsWe retrospectively reviewed the clinical records of gastrointestinal tumor patients who received mFOLFOX6, XELOX, or FOLFIRI chemotherapy at two institutions. All patients included were female and less than 55 years old, with no history of drinking. The patients were divided into two groups for olanzapine-containing triple therapy (olanzapine, tropisetron, and dexamethasone) and non-olanzapine dual therapy (tropisetron and dexamethasone). The study outcomes were complete response (CR), complete control (CC), nausea control, and quality of life (QoL) by the functional living index-emesis (FLIE) questionnaire.ResultsA total of 93 patients were included in the study (olanzapine: 40; control: 53). The CR rate in the olanzapine group was significantly higher than that in the control group in delayed and overall phase (75.0% vs 54.7%, p=0.044; 70.0% vs 47.2%; p=0.028). The CC rate in the overall phase was also better in the olanzapine group (62.5% vs 39.6%, p=0.029). The control of nausea in the overall phase showed a superior trend in the olanzapine group (p=0.059). The olanzapine group exhibited higher FLIE scores, which demonstrated better QoL. More patients in the olanzapine group exhibited somnolence and dizziness. Conversely, the incidence of insomnia and anorexia in the olanzapine group was lower.ConclusionThis retrospective study indicates that in gastrointestinal tumor patients with high-risk factors for CINV who were receiving MEC, olanzapine-containing triple antiemetic regimen exhibit better efficacy and QoL as compared to non-olanzapine dual regimen. Further randomized studies are required to confirm these results.

Sequential treatment with pazopanib followed by nivolumab in patients with renal cell carcinoma: Updated interim results of the non-interventional study PAZOREAL.

e17075 Background: Real-world evidence is urgently needed to monitor the translation of new treatment approaches into routine clinical practice as well as to improve cancer treatment and survivorship care. Methods: PAZOREAL is a prospective, multicenter, non-interventional study to evaluate effectiveness, tolerability, safety, and quality of life (QoL) in patients (pts) with advanced or metastatic renal cell carcinoma (mRCC) treated with 1st-line pazopanib (PAZO) followed by 2nd-line nivolumab (NIVO). The primary variable was time on drug (TD) in the respective treatment (Tx) lines. Other endpoints include overall survival (OS), safety and QoL evaluated by EQ-5D-5L. Results: Between December 2015 and September 2017, 414 pts were enrolled and 388 pts started first-line PAZO Tx, 136 pts subsequently received NIVO as second-line Tx. At time of data-cut (30 Sep 2019) median TD was 6.5 months (95%CI 5.7-7.6) for 1st-line PAZO and 4.6 months (95%CI 3.3-6.0) for 2nd-line NIVO. 9.0% of 1st-line PAZO pts and 5.9% of 2nd-line NIVO pts achieved a complete response and disease control rate was 58.0% (95% CI 53.0-62.8) and 44.9% (95% CI 36.8-53.2) for PAZO or NIVO, respectively. Median OS was 32.6 months (95% CI 28.0-38.9) for all pts, 32.6 months (95%CI 28.2-NA) for pts with 2nd-line NIVO and 32.3 months (95%CI 18.8-NA) for pts with other 2nd-line Tx. The most commonly reported treatment emergent AEs were diarrhea (37.2%), nausea (21.7%) and fatigue (19.1%) for PAZO Tx and diarrhea (8.8%), peripheral edema (5.9%) and dyspnea, fatigue, nausea, rash, vomiting (5.1% each) for NIVO. 66 pts (17.1%) discontinued PAZO and 7 pts (5.1%) discontinued NIVO due to related TEAEs. During 1st-line PAZO Tx, mean EQ-5D-5L utility scores initially decreased slightly by time, returned to baseline level and remained stable afterwards. During 2nd-line NIVO Tx the utility scores initially increased by time and remained stable thereafter. Similar tendencies were reported for mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Conclusions: The interim results of the PAZOREAL study confirm favorable clinical trial outcomes, the good benefit-risk profile and the sustained QoL in pts with mRCC in a real-world setting. The sequential treatment with PAZO followed by NIVO is effective and well tolerated. Clinical trial information: NIS-Nr.: 6687.

Effects of endolymphatic sac decompression combined with posterior tympanotomy with local steroids for intractable Meniere’s disease

Background: Endolymphatic sac decompression surgery (ESDS) is commonly used for intractable Meniere’s disease, but its effect remains controversial because of the low rate of vertigo control.Objectives: In the present study, we examined ESDS combined with posterior tympanotomy with local steroids as a new therapeutic strategy for intractable Meniere’s disease.Materials and methods: This retrospective study enrolled 19 patients with Meniere’s disease using ESDS combined with posterior tympanotomy with local steroids between 2015 and 2018. Postoperatively we recorded and evaluated changes in vertigo attack frequency and hearing level.Results: Vertigo episodes decreased from 3.6 ± 3.2 times preoperatively to 0.2 ± 0.5 times postoperatively, with 89.5% complete vertigo control rate. Mean PTA decreased from 40.5 ± 21.3 dB to 39.5 ± 17.5 dB postoperatively, with 21.1% improvement rate.Conclusions and significance: The present findings suggest that ESDS combined with posterior tympanotomy with local steroids could improve clinical results of hearing as well as vertigo control for intractable Meniere’s disease.

Long-term outcomes of triple semicircular canal plugging for the treatment of intractable Meniere's disease: A single center experience of 361 cases.

Meniere's disease is a common chronic inner ear disease. Because the definitive pathogenesis is still unknown, there is currently no cure for this disorder. Semicircular canal plugging (SCP), first used to treat patients with intractable benign paroxysmal positional vertigo, has since been applied to patients with intractable peripheral vertigo. This study was aimed to explore the long-term efficacy of triple semicircular canal plugging (TSCP) in the treatment of intractable Meniere's disease (MD) so as to provide a new method in the framework of treatment with MD. Three hundred and sixty-one unilateral MD patients, who were treated with TSCP in our hospital between Dec. 2010 and Sep. 2016, were recruited in this study for retrospective analysis. Vertigo control and auditory function were monitored during a period of two-year follow-up. Seventy three patients who were subjected to intratympanic gentamicin were selected as a control group. Pure tone audiometry, caloric test, vestibular evoked myogenic potential (VEMP) were performed in two-year follow-up. The total control rate of vertigo in TSCP group was 97.8% (353/361) in the two-year follow-up, with complete control rate of 80.3% (290/361) and substantial control rate of 17.5% (63/361). The rate of hearing loss was 26.3% (95/361). The total control rate of vertigo in intratympanic gentamicin group was 83.6% (61/73), with complete control rate of 63.0% (46/73) and substantial control rate of 20.5% (15/73). The rate of hearing loss was 24.7% (18/73). The vertigo control rate of TSCP was significantly higher than that of chemical labyrinthectomy(χ2 = 24.798, p < 0.05). There was no significant difference of hearing loss rate between two groups. (χ2 = 0.087, p > 0.05). Triple semicircular canal plugging (TSCP), which can reduce vertiginous symptoms in patients with intractable Meniere's disease (MD), represents an effective therapy for this disorder. It might become a new important method in the framework of treatment with MD.

Safety and efficacy analysis of microwave ablation in small hepatocellular carcinomas sized below 3 cm

PurposeThe aim of this study was to investigate the efficacy and safety of microwave ablation (MWA) in small hepatocellular carcinomas sized ≤ 3 cm, determine long-term survival, and identify prognostic factors for survival rates.Material and methodsIn this study, the radiological and laboratory findings obtained from 31 consecutive patients who underwent MWA were retrospectively evaluated. The survival periods and complication rates were analysed.ResultsMicrowave ablation was applied to 42 hepatocellular carcinoma nodules in 31 patients. The mean age of the patients was 61 ± 7.3 (median 62, range 46-78) years. The mean overall survival (OS) was 47.4 ± 3.3 months. The rates of cumulative OS in the first, second, and third years were 95.2%, 91.8%, and 79.2%, respectively. The mean disease-free survival (DFS) rate was 24.1 ± 2.5 months. The cumulative DFS rates in the first, second, and third years were 75.6%, 52.5%, and 28.2%, respectively. The number of tumours and tumour distribution were determined as prognostic factors. No major complication was detected, but six patients (13.9%) developed minor complications after MWA.ConclusionsMicrowave ablation in patients with hepatocellular carcinoma is a safety treatment modality with very low rates of complications. It offers an effective treatment with a high rate of complete response and local disease control according to the short-term results. In the long term, it prolongs the survival time of the treated patients. The number of tumours and tumour distribution were determined as prognostic factors affecting survival rates.

Comparison of Mirtazapine and Olanzapine on Nausea and Vomiting following Anthracycline-cyclophosphamide Chemotherapy Regimen in Patients with Breast Cancer.

We evaluated and compared the efficacy and safety of mirtazapine (MTZ) with olanzapine (OLP) for preventing chemotherapy-induced nausea and vomiting (CINV) following anthracycline plus cyclophosphamide (AC) regimen. Eligible participants were chemotherapy-naive early-stage breast cancer patients who were scheduled to undergo adjuvant AC. The patients were randomized to take oral MTZ or OLP in combination with aprepitant (A), dexamethasone (D), and granisetron (G), (ADG). The endpoints included rates of complete response (CR), complete control (CC), total control (TC), and adverse events during the acute, delayed, and overall phases in the two cycles of chemotherapy. The influence of CINV on the quality of life (QoL) was evaluated on day 6 of chemotherapy. Of 82 patients, 60 were randomized. In the first cycle, CR rates in cycle 1 were 83.3% and 76.6% during the acute period, 80% and 86.6% during the delayed period, and 66.6% and 63.3% during the overall period, for the ADG-M and ADG-O, respectively. High efficacy of both groups was maintained over 2 cycles. More patients in the ADG-M group noted minimal or no impact of CINV on daily life in cycle 2 (89.7% vs. 67.9%; p = 0.044). Incidence of somnolence and fatigue was more frequent with the olanzapine group. In this study, there was no substantial difference between mirtazapine and olanzapine in preventing CINV. Further large randomized trials are essential to demonstrate the anti-emetic effect of mirtazapine in chemotherapy.