Multiple Cycles Of Chemotherapy Research Articles

Laparoscopy in the diagnosis and treatment of peritoneal metastases

Over two decades the benefits of laparoscopy in the diagnosis and treatment of peritoneal metastases has been studied. Increasing utilization of this surgical tool has occurred with efficacy and safety demonstrated. The cancer surgery literature concerning the problem that peritoneal metastases presents, its adverse outcomes, and benefits of treatment were reviewed for patients with gastrointestinal malignancy. A major indication for laparoscopy is to determine the presence versus absence of peritoneal metastases. This may be especially important when planning treatments for gastric cancer. Repeated laparoscopy is used to monitor the efficacy of multiple cycles of intraperitoneal chemotherapy. Therapeutic laparoscopy involves the administration of hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with primary cancer who are at risk for subsequent peritoneal metastases or in those patients with peritoneal metastases diagnosed in follow-up. There are multiple applications of laparoscopy in patients with peritoneal metastases is indicated in many clinical situations as reviewed in this manuscript. Oftentimes, radiologic and laparoscopic assessments can be used to compliment each other.

SAT-586 Primary Fallopian Tube Carcinoma Metastasizing to the Thyroid Gland: A Rare Cause of Hypothyroidism

Background: Primary fallopian tube carcinoma (PFTC) has been considered to account for only about 0.1-0.5% of all gynecologic cancers. It is notorious for metastasis to the ovaries, omentum, and uterus but has never been reported to present with hypothyroidism as a metastatic thyroid nodule. Case: A 53-year-old female presented with fatigue, generalized weakness and constipation for the last 4 months. Her past medical history was significant for stage IV poorly differentiated PFTC status post total abdominal hysterectomy, omentectomy and tumor debulking due to the local spread of the PFTC. She also underwent multiple cycles of chemotherapy with paclitaxel, cisplatin, doxorubicin and bevacizumab and was declared in remission by her oncologist. On examination, her vital signs were stable. Thyroid examination showed palpable nodules in the right and left lobes. Her laboratory investigation revealed normal liver and renal function tests, but the blood chemistry was significant for raised TSH levels of 68.8 mcIU/ml and decreased T3 and T4 levels of 45 ng/dL and 0.54 ng/dL respectively. Thyroid Peroxidase Antibody level was less than 3 IU/ml (reference range <6 IU/ML). Thyroid ultrasound showed a 2.3 x 0.7 x 2 cm solid nodule in the medial lower pole of the right lobe with and a 1.9 x 0.8 x 1.1 cm solid nodule in the medial lower pole of left lobe with increased vascularity. The fine needle aspiration cytology revealed groups of highly atypical cells showing enlarged, irregular, crowded nuclei which were intermixed with scattered bland follicular cells and macrophages. These atypical cells were identical to the serous carcinoma cells seen on previous PFTC specimens, confirming the hematogenous spread of PFTC to the thyroid gland. This diagnosis was further substantiated by immunohistochemical staining, which showed two different populations of cells, thyroid cells stained positive for TTF-1 (Thyroid transcription factor-1) while other cells were positive for WT-1 immunohistochemical stain strongly suggestive of metastatic serous carcinoma. Her serum cancer antigen 125 (CA 125) was also found to be elevated at 395 U/ml (normal range 0-35 U/ML) suggesting recurrence of PFTC. Niraparib chemotherapy was initiated. She was also started on 75 mcg of Levothyroxine per day. TSH levels after two months were 4.2 mcIU/ml. Conclusion: PFTC can be diagnosed early in its course using transvaginal Doppler ultrasound to detect areas of neovascularization within the fallopian tube. PFTC has histological and clinical resemblance with ovarian and uterine primaries and hence can be challenging to diagnose. It is incredibly uncommon to suspect thyroid metastasis from the residuals of PFTC as a possible etiology of hypothyroidism. Thus, physicians should keep a very high index of suspicion in appropriate clinical settings. Prognosis remains poor as most patients present with metastatic disease.

Laparoscopy in the diagnosis and treatment of peritoneal metastases

Over two decades the benefits of laparoscopy in the diagnosis and treatment of peritoneal metastases has been studied. Increasing utilization of this surgical tool has occurred with efficacy and safety demonstrated. The cancer surgery literature concerning the problem that peritoneal metastases presents, its adverse outcomes, and benefits of treatment were reviewed for patients with gastrointestinal malignancy. A major indication for laparoscopy is to determine the presence versus absence of peritoneal metastases. This may be especially important when planning treatments for gastric cancer. Repeated laparoscopy is used to monitor the efficacy of multiple cycles of intraperitoneal chemotherapy. Therapeutic laparoscopy involves the administration of hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with primary cancer who are at risk for subsequent peritoneal metastases or in those patients with peritoneal metastases diagnosed in follow-up. There are multiple applications of laparoscopy in patients with peritoneal metastases is indicated in many clinical situations as reviewed in this manuscript. Oftentimes, radiologic and laparoscopic assessments can be used to compliment each other.

EFFECT OF USING GINGER TEA ON CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING AMONG WOMEN WITH CANCER

Background: Chemotherapy-induced nausea and vomiting (CINV) remains a significant reason of distress and dissatisfaction among patients getting cancer treatment. Aim: The aim of this study is to assess the effect of ginger tea on chemotherapy induced nausea and vomiting in women with cancer. Study Design: A quasi-experimental research design. Sampling: A purposive sample of 100 women with gynecological and breast cancer. Setting: This study was conducted at the outpatient clinics of oncology and nuclear medicine department affiliated to Ain Shams University Hospital. Tools: Three tools were used for the data collection of this study I. A Patient interview questionnaire included patients’ demographic and clinical data, II. Simplified form of Rhodes index of nausea, vomiting and retching assessment scale. III. Patients ‘satisfaction questionnaire Results: The mean age of all patients was 5.84+36.79 years, 17 (34%) of the patients in the control group had secondary educational level, while 19 (38%) in experimental group were university graduates. 35 (70%) and 36 (72%) of patients in the control group and experimental group were married. (54%, 60%) of patients in the control group and experimental group were employed. Regarding total vomiting and nausea experience score, there was no significant difference between both groups before research intervention and during the first 6, 12 & 24 hours after chemotherapy. However, there was a statistically significant association in intervention (ginger tea group) and control group on the second day, third day and fourth day post chemotherapy (p = <0.001). Conclusions and recommendations: The current study showed that ginger tea can be administered to patients with gynecologic and breast cancer as a safe herbal medicine for effective prevention of chemotherapy-induced nausea and vomiting. Prospective studies and longer periods of follow up are also helpful to assess the efficacy of ginger supplementation on the prevalence of CINV symptoms in patients receiving multiple cycles of chemotherapy.

EFFECT OF USING GINGER TEA ON CHEMOTHERAPY- INDUCED NAUSEA AND VOMITING AMONG WOMEN WITH CANCER

Background: Chemotherapy-induced nausea and vomiting (CINV) remains a significant reason of distress and dissatisfaction among patients getting cancer treatment. Aim: The aim of this study is to assess the effect of ginger tea on chemotherapy induced nausea and vomiting in women with cancer. Study Design: A quasi-experimental research design. Sampling: A purposive sample of 100 women with gynecological and breast cancer. Setting: This study was conducted at the outpatient clinics of oncology and nuclear medicine department affiliated to Ain Shams University Hospital. Tools: Three tools were used for the data collection of this study I. A Patient interview questionnaire included patients‘ demographic and clinical data, II. Simplified form of Rhodes index of nausea, vomiting and retching assessment scale. III. Patients ‗satisfaction questionnaire Results: The mean age of all patients was 5.84+36.79 years, 17 (34%) of the patients in the control group had secondary educational level, while 19 (38%) in experimental group were university graduates. 35 (70%) and 36 (72%) of patients in the control group and experimental group were married. (54%, 60%) of patients in the control group and experimental group were employed. Regarding total vomiting and nausea experience score, there was no significant difference between both groups before research intervention and during the first 6, 12 & 24 hours after chemotherapy. However, there was a statistically significant association in intervention (ginger tea group) and control group on the second day, third day and fourth day post chemotherapy (p = <0.001). Conclusions and recommendations: The current study showed that ginger tea can be administered to patients with gynecologic and breast cancer as a safe herbal medicine for effective prevention of chemotherapy-induced nausea and vomiting. Prospective studies and longer periods of follow up are also helpful to assess the efficacy of ginger supplementation on the prevalence of CINV symptoms in patients receiving multiple cycles of chemotherapy.

Repeated chemotherapy cycles produced progressively worse and enduring impairments in the sleep–wake profile of hospitalized breast cancer patients

ABSTRACT Cross-sectional studies, conducted previously, reported disruption of the sleep–wake rhythms of cancer patients on chemotherapy. Although few studies highlighted the effect of hospitalization on sleep, no data were obtained on the effects of longitudinal repeated chronotherapy cycles on sleep pattern of cancer patients. In this study, using the two-factor repeated-measures design, we attempted to assess longitudinally the quality and pattern in sleep–wake behavior of breast cancer in- and outpatients, who received multiple cycles of chemotherapy. We randomly selected the patients from the Regional Cancer Center, Dr. B.R. Ambedkar Memorial Hospital, Raipur, India. We used wrist-worn actigraphs to record the sleep–wake pattern both objectively and subjectively. Additionally, we administered Pittsburgh Sleep Quality Index questionnaire to each patient. Results revealed statistically significant effects of chemotherapy with and without hospitalization mostly on all objective [total sleep time, sleep onset latency, wake after sleep onset, fragmentation index, and sleep efficiency (SE)] and subjective [duration of sleep, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, SE, and overall sleep quality] sleep–wake parameters of cancer patients. Cancer patients, who received repeated chemotherapy administration followed by hospitalization on each occasion, experienced severely impaired sleep–wake cycle as compared with those who went home after receiving chemotherapy.

Beau’s Lines Resulting from Taxane Chemotherapy

Nail abnormalities are frequently found in oncologic patients who have undergone chemotherapy. Although thesechanges do not require treatment, they could influence the treatment plan and the patient’s quality of life. Some naildisorders lead to severe complications. Herein, the author reports on a patient with advanced breast cancer who received multiple kinds and cycles of chemotherapy. She developed multiple, parallel, transverse grooves, compatible with Beau’s lines, on the nail plate of all her fingernails and toenails. This report aims to further the knowledge of medical students, physicians, and healthcare providers regarding the nails of patients who receive chemotherapy.

Acquired Deficiency of Von Willebrand Factor (wWF) Associated with Intestinal Angiodysplasia

Acquired von Willebrand's Disease (AVWD) is a rare bleeding disorder that has been associated with angiodysplasia. We present a 79-year-old gentleman that presented with gradually progressive generalized weakness and easy fatigability with history of recurrent self-limiting epistaxis. He is known to have chronic lymphocytic leukemia (CLL), multiple myeloma and acquired Von Willebrand factor deficiency (Ristocetin cofactor of 25%) for which he received multiple chemotherapy cycles, last was two weeks before admission. Examination was evident of pallor with no signs of active epistaxis. Labs showed Hb of 4.8 g/dl, WBC of 8,400 and Platelets of 150,000. Ferritin was 4.64. He received 3 packed RBC's with improvement of his hemoglobin to 9.1 g/dl. Given inactive bleeding he was discharged for outpatient upper and lower endoscopy. Two weeks later he presented with same complain and was found to have Hb of 6.4. He denies any further epistaxis, neither hematemesis, melena or hematochezia. Colonoscopy was done showing diffuse diverticulosis and hyperplastic polyp. Enteroscopy was done showing bleeding angioectasia in the second portion of the duodenum. The bleeding site was coagulated multiple times using a heater probe set at 20J and resulted in cessation of the bleeding. Given the multiple coagulations further advancement of the enteroscope was deferred. Video capsule endoscopy was done with no further small bowel lesions. Hb stayed stable overnight and he was discharged with close clinic follow up Acquired von Willebrand syndrome (AVWS) is a rare and probably underestimated bleeding disorder which mimics most of the clinical symptoms and laboratory features of hereditary von Willebrand disease (VWD) in patients devoid of both personal and family history of bleeding diathesis. The diagnosis and treatment of recurrent GI bleeding in acquired VWD remains challenging and is associated with significant morbidity.1955_A Figure 1. Bleeding angiodysplasia in the second part of the duodenum1955_B Figure 2. Bleeding angiodysplasia in the second part of the duodenum1955_C Figure 3. Successful control of bleeding with coagulation using a heater probe

Neuroblastoma: clinical and biological approach to risk stratification and treatment.

Neuroblastoma is the most common extra-cranial solid tumor of childhood and the most common in the first year of life. It is a unique malignancy in that infants often present with either localized or metastatic disease that can spontaneously regress without intervention while older children can succumb to the disease after months to years of arduous therapy. Given this wide range of outcomes, the International Neuroblastoma Risk Group was created to stratify patients based on presenting characteristics and tumor biology in order to guide intensity of treatment strategies. The goal has been to decrease therapy for low-risk patients to avoid long-term complications while augmenting and targeting therapies for high-risk patients to improve overall survival. The international risk stratification depends on age, stage, histology, MYCN gene amplification status, tumor cell ploidy and segmental chromosomal abnormalities. Treatment for asymptomatic low-risk patients with an estimated survival of > 98% is often observation or surgical resection alone, whereas intermediate-risk patients with an estimated survival of > 90% require moderate doses of response-adjusted chemotherapy along with resection. High-risk patients undergo multiple cycles of combination chemotherapy before surgery, followed by consolidation with myeloablative autologous hematopoietic stem cell transplantation and local radiation and finally immunotherapy with differentiation therapy as maintenance phase. With this approach, outcome for patients with neuroblastoma has improved, as the field continues to expand efforts in more targeted therapies for high-risk patients.

Changes in upper extremity function, ADL, and HRQoL in colorectal cancer patients after the first chemotherapy cycle with oxaliplatin: a prospective single-center observational study

PurposeOxaliplatin, an important chemotherapeutic agent in colorectal cancer, causes chemotherapy-induced peripheral neuropathy (CIPN), for which prophylactic or therapeutic interventions are lacking. We aimed to investigate changes in upper extremities, activities of daily living (ADL), and health-related quality of life (HRQoL) parameters after the first chemotherapy cycle.MethodsThirty-eight colorectal cancer patients scheduled to receive the leucovorin, 5′-fluorouracil, oxaliplatin (FOLFOX) therapy or the capecitabine, oxaliplatin (CAPOX) therapy, participated. Patients underwent objective assessment of sensory function, muscular strength, and manual dexterity and answered the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and the Disabilities of the Arm, Shoulder, and Hand-Disability/Symptom (DASH-DS) questionnaires for subjective assessment. The CIPN was assessed at baseline and prior to the second drug cycle.ResultsLight touch sensation in both hands worsened significantly after the first drug cycle, though no significant changes were observed in muscular strength and manual dexterity. The QLQ-C30 analysis showed that Physical Functioning, Role Functioning, Nausea and Vomiting, and Dyspnea were significantly worse, whereas Emotional Functioning was improved. The DASH-DS analysis revealed significant worsening of dysfunction and subjective symptoms.ConclusionsOur results suggest that light touch sensation may worsen even in the absence of multiple chemotherapy cycles. Even if arm and hand function (muscular strength and manual dexterity) is apparently intact, patients may experience dysfunction and decreased HRQoL. For preserving or improving patients’ ADL and HRQoL, it is imperative to provide support at chemotherapy initiation.

329 Unique Genomic Alterations in a Case of Splenic Angiosarcoma

Angiosarcoma of the spleen is an uncommon condition, comprising only 2.7% of all angiosarcomas. It is common for splenic angiosarcoma to metastasize to other organs. The diagnosis of splenic angiosarcoma is made by either acute abdominal symptoms after splenic rupture or incidentally from radiologic surveillance. We report herein a case of splenic angiosarcoma with documented unique genomic mutations that have not been previously reported. An 81-year-old man presented with thrombocytopenia and progressive splenomegaly over several years; a diagnosis of immune thrombocytopenia purpura was initially made. The patient subsequently developed sclerotic-blastic bone lesions with worsened splenomegaly. Bone marrow and bone biopsies revealed angiosarcoma, which was considered to be metastatic from the spleen based on imaging. He received multiple cycles of chemotherapy with minimal improvement. Eventually, the patient underwent splenectomy and the diagnosis of primary splenic angiosarcoma was made. Tissue sections showed a mitotically active cellular spindle cell neoplasm with pleomorphic nuclei, diffusely configured in anastomosing vasoformative channels. Zones of fibrosis, infarction, or active tumor necrosis comprised less than 5% of the splenic volume. Metastases to lymph nodes, peripancreatic fat and bone marrow were documented. Immunostains showed diffuse and strong immunoreactivity for CD31 and CD34, supporting a vascular origin. Molecular testing showed mutations in the following genes: ATRX, CDKN2A/B, EPHA3, MLL2, NOTCH2, and TET2. Primary splenic angiosarcoma is a rare entity with limited published molecular data. To our knowledge, the composite of genomic mutations outlined herein have not been previously reported in splenic angiosarcomas. CDKN2A/B has been reported in hepatic angiosarcomas.

Fungating Stage-4 Penile Squamous Cell Carcinoma

Clinical-medical Image The patient is a 46-year-old male with past medical history significant for stage-4 squamous cell carcinoma of the penis. He had been treated with multiple cycles of radiotherapy and chemotherapy with cisplatin for 3-4 weeks, with subsequent addition of 5-fluorouracil for better efficacy. Patient eventually became non-compliant with radiotherapy and chemotherapy, and decided to stop attending follow-up office visits with his oncologist. He had not been feeling any pain during the time of increasing growth of the cancer. He was admitted to the hospital for neutropenic fever with altered mental status and exhibited a sun downing effect consistent with delirium. Basic metabolic panel revealed hypercalcemia with normal sodium levels, implicating hypercalcemia of malignancy as the etiology of his confusion. His physical exam was remarkable for extension of the penile cancer deep into the pelvis with pelvic disfigurement, as well as dry oral mucosa, decreased skin turgor, sunken eyes, and low urine output. His mental status improved upon administration of IV normal saline, IV haloperidol, and reversal of sun downing through bright light therapy and music therapy. Given the poor prognosis of the patient, a discussion about hospice care took place, and the patient was agreeable to hospice care.

Distinct Trajectories of Fatigue and Sleep Disturbance in Women Receiving Chemotherapy for Breast Cancer.

To examine self-reported severity of fatigue and disturbed sleep experienced daily by women with breast cancer during multiple cycles of chemotherapy, exploring potential classes of women experiencing similar symptom trajectories. . In a secondary analysis, classes of women experiencing similar patterns of fatigue and disturbed sleep were identified. . Oncology clinics in the United States. . 166 women with breast cancer receiving chemotherapy. . Severity scores were self-reported daily using an automated system. Classes of fatigue and disturbed sleep severity were identified using latent growth mixture modeling. . Fatigue, disturbed sleep, age, stage of disease, education, employment, marital status, chemotherapy regimen, hours lying down, and missed work. . Three fatigue classes were identified. Patterns of symptom trajectories for fatigue and disturbed sleep were distinguished by baseline symptom severity. . Identification of women at risk for fatigue and disturbed sleep may allow clinicians to intensify symptom management.

Preventing chemotherapy-induced nausea and vomiting in patients with lung cancer: efficacy of NEPA (netupitant-palonosetron), the first combination antiemetic

PurposePatients receiving platinum-based chemotherapy are at high risk of chemotherapy-induced nausea and vomiting (CINV), a distressing side effect of treatment. This post-hoc subgroup analysis of two pivotal trials evaluated the efficacy of NEPA in preventing CINV in subsets of patients with lung cancer who received cisplatin or carboplatin.MethodsIn each study, the efficacy endpoints complete response (CR; defined as no emetic episodes and no rescue medication) and no significant nausea (NSN; defined as a score of < 25 mm on a visual analog scale of 0–100 mm) during the acute (0–24 h), delayed (25–120 h), and overall (0–120 h) phases post-chemotherapy in cycle 1 (study 1) and cycles 1–4 (study 2) were assessed. Safety was evaluated by recording treatment-emergent adverse events (AEs) and treatment-related AEs.ResultsNEPA treatment resulted in high CR rates across the acute, delayed, and overall phases (cisplatin: > 88% overall CR; carboplatin: > 75% overall CR), with higher CR rates for NEPA-treated patients than those receiving palonosetron; moreover, CR rates were sustained over multiple chemotherapy cycles (> 75%). High rates of NSN observed during cycle 1 (> 79%) were also maintained over multiple chemotherapy cycles. NEPA was well tolerated in all patients.ConclusionsNEPA appears to be effective and well tolerated in patients with lung cancer receiving platinum-based chemotherapy, across the acute, delayed, and overall phases and throughout multiple cycles. As a highly effective oral combination antiemetic agent administered as a single dose once per cycle, NEPA may offer a convenient, simplified prophylactic antiemetic.

Rolapitant: A Review in Chemotherapy-Induced Nausea and Vomiting

Oral rolapitant (Varubi™; Varuby®), a long-acting neurokinin-1 (NK1) receptor antagonist (RA), is indicated in the USA and EU as part of an antiemetic regimen to prevent delayed chemotherapy-induced nausea and vomiting (CINV) in adults receiving highly or moderately emetogenic chemotherapy (HEC or MEC). In randomized, phase III trials, a single oral dose of rolapitant 180 mg was effective in preventing delayed CINV compared with placebo, when each was used in combination with a 5-HT3 RA plus dexamethasone, in adults receiving their first course of HEC or MEC. The benefits of rolapitant were maintained over multiple cycles of chemotherapy. The tolerability profile of rolapitant is similar to that of placebo and consistent with that of other NK1 RAs. However, rolapitant differs from other existing NK1 RAs in that it does not interact with CYP3A4, thereby negating the need for dexamethasone dose adjustments and potentially making rolapitant a more suitable option for patients receiving CYP3A4 substrates. Thus, oral rolapitant is an effective and well tolerated NK1 RA that expands the treatment options for preventing delayed CINV in adults receiving HEC or MEC.

Analysis of short-term efficacy and pathological outcome of paclitaxel plus platinum as neoadjuvant chemotherapy in the treatment of locally advanced cervical cancer.

e17002 Background:The purpose of this study is to observe the short-term efficacy and pathological outcomes of paclitaxel combined with platinum (TP) as neoadjuvant chemotherapy (NACT) regimen in patients with locally advanced cervical cancer (LACC). Methods: This is a prospective study involving 61 women with histologically confirmed LACC referred for NACT at Beijing Obstetrics and Gynecology Hospital between April 2013 and January 2015. Results: The short-term efficacy of NACT was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST). The short-term efficacy of NACT was 91.8% (complete remission and partial remission). The cervical invasion ≤1/2 was 82.4% in the complete remission (CR) group, 46.2% in the partial remission(PR) group and 20% in the stable disease (SD) group. The difference between groups was statistically significant (p=0.012). The slides of all surgical specimens were reviewed and classified according to Tumor Regression Grade (TRG). The good response was defined by good short-term efficacy (RECIST) and the difference between the groups was statistically significant (p=0.042). The short-term efficacy of NACT in artery intervention (AI) group (70-80%) was better than that in intravenous (IV) group (20%-30%) and the difference was statistically significant (p=0.011). The patients with tumor diameter ≤5cm and multiple cycles of chemotherapy have good short-term efficacy of NACT in LACC. All patients were followed up to the last day of 2015 with the median follow-up time of 21.5 months for NACT. For the 61 patients referred for NACT in LACC, two patients had relapsed and 1 patient died from the disease. Conclusions: The study showed that the Paclitaxel plus platinum as NACT for LACC treatment had a significant local effects. It could reduce tumor myometrial invasion and regress tumor. The short-term efficacy of the treatment in the AI group was more effective than in the IV group, two cycles of NACT of AI treatment to LACC patients would obtain an optimal short-term efficacy. Clinical trial information: NCT02471027.

Efficacy of NEPA (netupitant/palonosetron) across multiple cycles of chemotherapy in breast cancer patients: A subanalysis from two phase III trials

ObjectivesBreast cancer (BC) patients represent a high-risk population for experiencing chemotherapy-induced nausea and vomiting (CINV), since they frequently receive highly emetogenic anthracycline-cyclophosphamide–based (AC) chemotherapy, and are often female and young, two predisposing risk factors for CINV. Guidelines recommend the combination of a neurokinin-1 receptor antagonist (NK1RA), 5-hydroxytryptamine-3 RA (5-HT3RA), and dexamethasone (DEX) for CINV prophylaxis in AC-treated patients. This post-hoc analysis evaluated the efficacy of NEPA, a fixed combination of netupitant (NETU [NK1RA]) and palonosetron (PALO [5-HT3RA]) in BC patients from two phase III studies. MethodsOverall, 1460 BC patients received AC (Study 1) or non-AC (Study 2) therapy over 6060 cycles. Randomized patients received DEX with either NEPA or oral PALO (Study 1), or NEPA or aprepitant+oral PALO (Study 2) before chemotherapy. ResultsIn AC-receiving patients, overall complete response (CR) rates with NEPA+DEX were statistically significantly higher than oral PALO+DEX rates (cycles 1–4: 73.9% vs 65.9%, 80.0% vs 66.0%, 83.6% vs 69.9%, 83.6% vs 74.4%, respectively). Overall, no significant nausea (NSN) rates were also superior with NEPA+DEX vs oral PALO+DEX (respectively, 74.2%–79.9% vs 68.5%–74.9%). A greater proportion of NEPA+DEX patients experienced “no-impact-on-daily-life” due to CINV (78.4% vs 71.4%) in cycle 1. In non-AC–receiving patients, prophylaxis with NEPA+DEX resulted in high CR and NSN rates across 1–4 chemotherapy cycles; no formal comparison with the control arm was performed. ConclusionNEPA+DEX administered as a single dose is an effective option for preventing CINV in BC patients receiving AC and non-AC, across multiple chemotherapy cycles. Clinical trials registration numbersStudy 1: NCT01339260, Study 2:NCT01376297.

Abstract P5-11-15: Rolapitant for the prevention of chemotherapy-induced nausea and vomiting in breast cancer patients receiving multiple cycles of emetogenic chemotherapy

Abstract Background: Patients (pts) with breast cancer often receive highly emetogenic chemotherapy, such as anthracycline plus cyclophosphamide (AC). Additionally, young age and female gender are risk factors for chemotherapy-induced nausea and vomiting (CINV) in response to emetogenic chemotherapy. We assessed the ability of the long-acting neurokinin-1 receptor antagonist (RA), rolapitant, in the prevention of CINV over multiple cycles in pts with breast cancer Methods: This is a post hoc analysis of the prevention of CINV in a subset of pts with breast cancer from 3 similarly-designed, randomized, placebo-controlled phase 3 trials in which pts received a single oral dose of 180 mg rolapitant or placebo before chemotherapy. All pts received an oral 5-HT3 RA + dexamethasone (active control). The regimens were cisplatin-based (n=36), AC-based (n=681) or other (n=166; carboplatin, cyclophosphamide, etc). Pts who completed cycle 1 could continue the same antiemetic treatment in multiple cycles. Endpoints for cycle 1 of chemotherapy included complete response (CR; no emesis and no use of rescue medication) and no emesis, and no nausea (maximum visual analogue scale [VAS] &amp;lt;5 mm), in the overall (0–120 h), acute (≤24 h), and delayed (&amp;gt;24–120 h) phases. On days 6-8 of each subsequent chemotherapy cycle, pts self-reported the incidence of emesis or nausea interfering with normal daily life. Results: In cycle 1, CR in both the overall (62.9% rolapitant, 55.1% control; p=0.018) and delayed (66.7% rolapitant, 59.7% control; p=0.032) phases were higher with rolapitant vs control . Rolapitant also improved no emesis rates in the overall (74.4% rolapitant, 62.6% control; p&amp;lt;0.001) and delayed (77.2% rolapitant, 68.5% control; p=0.004) phases. Although less pts were available for follow up over multiple cycles, a numerically greater proportion of rolapitant-treated pts than control pts reported no emesis (cycles 2-6) and no interfering nausea (cycles 2-5) (table). The incidence of treatment-emergent adverse events (TEAEs) was similar for rolapitant (85.2%) and control (83.2%) during cycles 1-6. The most common TEAEs occurred at comparable rates in the rolapitant and control arms: fatigue (28.5% and 29.4%, respectively), alopecia (28.5% and 31.2%, respectively), and constipation (20.0% and 20.9%, respectively). Conclusions: Rolapitant added to 5-HT3 RA and dexamethasone therapy improved CINV control and was safe and well-tolerated in pts with breast cancer receiving multiple cycles of emetogenic chemotherapy, mostly AC and carboplatin, historically a high-risk population for CINV. Pt-Reported Response in Multiple Cycles, % (n/N)* No Emesis No Interfering Nausea CycleRolapitant 180 mgActive Controlp-value *Rolapitant 180 mgActive Controlp-value *288.3 (323/366)80.0 (308/385)0.00271.6 (262/366)68.3 (263/385)0.329390.5 (297/328)80.5 (293/364)&amp;lt;0.00173.8 (242/328)65.9 (240/364)0.025487.5 (266/304)82.4 (277/336)0.07579.3 (241/304)72.0 (242/336)0.033594.9 (111/117)88.2 (127/144)0.05987.2 (102/117)80.6 (116/144)0.152695.3 (102/107)88.9 (120/135)0.07184.1 (90/107)83.0 (112/135)0.811* Unstratified Cochran-Mantel-Haenszel test for between rolapitant and control difference in response rate. Citation Format: Schwartzberg L, Navari R, Arora S, Powers D, Jordan K, Rapoport B. Rolapitant for the prevention of chemotherapy-induced nausea and vomiting in breast cancer patients receiving multiple cycles of emetogenic chemotherapy [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-11-15.

Rolapitant in the Current Management of Chemotherapy-induced Nausea and Vomiting

Chemotherapy-induced nausea and vomiting (CINV) has a severe detrimental effect on the quality of life of patients with cancer receiving chemotherapy, and remains one of the most feared adverse events associated with chemotherapy. However, physicians and oncology nurses often underestimate the incidence of CINV, as well as the impact of this toxicity on patients’ daily lives. Many challenges remain in the prevention and treatment of CINV, particularly in the delayed phase. The 5-hydroxytryptamine type 3 receptor antagonists (5-HT3 RAs) have demonstrated efficacy in CINV control during the acute phase (≤24 hours) but have limited utility in the delayed phase (&gt;24–120 hours). The more recently introduced neurokinin-1 (NK-1) RAs have represented a relevant improvement in the prevention of CINV associated with the administration of highly and moderately emetogenic chemotherapy, particularly in the delayed phase. One of these, rolapitant, when given as one dose on the first day of the chemotherapy cycle, has been shown to protect against CINV during the complete cycle of chemotherapy in randomised controlled trials, as well as being effective in multiple cycles of chemotherapy.

EARLY RECURRENCE OF WELL-DIFFERENTIATED ENDOMETRIAL CANCER (A CASE REPORT)

Endometrial cancer is the 6-th most common malignancy in women worldwide, accounting for about 4.8 % of all female cancers. The treatment of recurrent endometrial cancer remains a major challenge. Some endometrial cancer recurrences, for example vaginal stump recurrence, are reported to be effectively treated with surgical resection and radiation therapy. Early recurrence of early-stage well-differentiated endometrial cancer is uncommon. Case report. Herein we report a rare case of recurrent well-differentiated endometrial cancer in a 65-year-old woman. The patient had recurrence 10 months after laparoscopic hysterectomy with bilateral salpingo-oophorectomy. Recurrent endometrial tumor with extension into the rectosigmoid colon, urinary bladder and the right ureter manifested itself clinically with severe pain requiring the use of opioids. The recurrent tumor was removed. Resection of the bladder, left ureter and upper ampular rectum was followed by anastomosis. The patient received multiple cycles of chemotherapy. Conclusion. Compliance with the principles of ablastics during the laparoscopic or laparotomic surgery helps to avoid recurrence in patients with prognostically favorable cancer. In case of recurrence, combined operations are the only possible chance of improving survival of patients with locally advanced or recurrent tumors, which are insensitive to chemoradiotherapy.