Natalie Pulenzas

Efficacy and safety of palonosetron for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis of randomized controlled trials

PurposePalonosetron, a 5-hydroxytryptamine 3 receptor antagonist (5-HT3RA) with a strong binding affinity and long half-life, has been used in numerous trials for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV). We systematically reviewed the efficacy and safety of palonosetron compared to other 5-HT3RAs in CINV prophylaxis.MethodsA literature search of Ovid MEDLINE, EMBASE, and CENTRAL was conducted to identify randomized controlled trials (RCTs) comparing palonosetron to other 5-HT3RAs in CINV prophylaxis. Primary endpoints were the percentage of patients achieving a complete response (CR), complete control (CC), no emesis, no nausea, or taking no rescue medications. Secondary endpoints were the percentage of patients suffering from 5-HT3RA-related adverse events.ResultsSixteen RCTs were identified with 2,896 patients randomized to palonosetron and 3,187 patients randomized to other 5-HT3RAs. Palonosetron was consistently statistically superior in CR, CC, no emesis, or no nausea and was sometimes superior in no rescue medication. Subgroup analyses demonstrated similarity in efficacy between highly and moderately emetogenic chemotherapy cohorts. In the acute phase, statistical superiority of palonosetron was found for trials that did not allow dexamethasone; conversely, RCTs that administered dexamethasone to all patients were nonsignificant. Palonosetron was statistically significantly safer in dizziness and mean QTc interval change and similar in constipation, headache, and diarrhea. Clinical superiority of palonosetron was reached in 3 of 19 analyzed efficacy and safety endpoints.ConclusionsPalonosetron is safer and more efficacious than other 5-HT3RAs. Future antiemetic guidelines should discuss the merits of including palonosetron as a first-line treatment.

Cut points for mild, moderate, and severe pain among cancer and non-cancer patients: a literature review

Defining cut points (CPs) for varying levels of pain intensity is important for assessing changes in patients functional status, and guiding the development and evaluation of treatment options. We aimed to summarize CPs identified in the literature for mild, moderate, and severe pain on the numeric rating scale (NRS), and recommend optimal CPs for cancer and non-cancer patients. We searched MEDLINE and EMBASE (inception to May 2015) for studies that used CPs to classify pain intensity on the NRS among patients with cancer or non-cancer conditions leading to acute or chronic pain. A CP was defined as the upper bound of a mild or moderate pain category. Of 1,556 identified articles, 27 were included for review. Among patients with cancer pain, mild-moderate pain CPs ranged from 1 to 4 (mean, 3.5±1.08), with CP4 being the most recommended CP (80%). For moderate-severe pain, CPs ranged from 4 to 7 (mean, 6.2±0.92), and CP6 (50%) was the optimal CPs. Among patients with non-cancer pain, mild-moderate pain CPs ranged from 2 to 5 (mean, 3.62±0.78), and CP4 was the most frequently used CP (52.9%). For moderate-severe non-cancer pain, CPs ranged from 4 to 8 (mean, 6.5±0.99), and CP6 (41.2%) was the most frequently recommended CP. A wide range of CPs for mild, moderate, and severe pain categories were identified in the literature among both cancer and non-cancer patient populations. Further studies are needed to delineate more accurate and precise CPs for pain intensity.

EORTC QLQ-BR23 and FACT-B for the assessment of quality of life in patients with breast cancer: a literature review

BACKGROUNDnThis study aims to compare the development, characteristics and validity of two widely used tools in the breast cancer population, the EORTC QLQ-BR23 and the FACT-B.nnnMETHODSnA literature search was conducted using Ovid MEDLINE, OLDMEDLINE, Embase, Embase Classic and the Cochrane Central Register of Controlled Trials to identify relevant studies.nnnRESULTSnBoth tools were found to be reliable and valid. The QLQ-BR23 focuses on physical function, whereas the FACT-B emphasizes emotional well-being. Scoring, item format, organization and response options differ between questionnaires.nnnCONCLUSIONnOverall, both questionnaires are effective in assessing breast cancer-specific quality of life. Clear similarities and differences between the two tools exist. Decision-making between the questionnaires should be based on the purpose and design of the study.

Quality of life (QOL) and symptom burden (SB) in patients with breast cancer

PurposeThe purpose of this study was to determine the quality of life (QOL) and symptom burden (SB) among breast cancer patients.MethodsPatients with DCIS, early stage, locally advanced, or metastatic breast cancer completed the Edmonton Symptom Assessment System (ESAS) and the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B). Patients were divided into subsequent cohorts based on their last day of treatment, age at enrollment, radiation, chemotherapy, and hormone therapy.ResultsA total of 1513 patients were enrolled. Metastatic patients had a lower QOL and greatest SB compared to all other patient groups. Patients ≤50xa0years old with early stage or locally advanced breast cancer had a lower QOL and greater SB for fatigue, depression, and anxiety compared to all other age cohorts. Patients with early stage breast cancer who received chemotherapy had a lower QOL and greater SB. Patients taking selective estrogen receptor modulator (SERM) had greater SB for depression and lower QOL compared to those not on SERM. Patients 2–10xa0years post-treatment had a lower QOL compared to patients ≥10xa0years post-treatment.ConclusionPatients ≤50xa0years old, 2–10xa0years post-treatment, treated with chemotherapy or SERM had increased SB and decreased QOL. Individualized interventions and programs can be developed to tailor to physical, educational, and psychosocial needs identified across the breast cancer continuum.

Update on the management of chemotherapy-induced nausea and vomiting – focus on palonosetron

Purpose Nausea and vomiting are major adverse effects of chemotherapy and can greatly impact patients’ quality of life. Although chemotherapy-induced nausea and vomiting (CINV) prevalence is high, treatment remains difficult. Palonosetron is a 5-hydroxytryptamine receptor antagonist (5-HT3RA) approved for treatment of CINV. The purpose of this review is to discuss existing and emerging therapeutic options, and examine studies focusing on palonosetron with regards to efficacy, pharmacology, tolerability, safety, and patient-derived outcomes. Methods A literature search was conducted using Ovid MEDLINE and EMBASE to identify relevant studies using palonosetron alone or in combination with other antiemetics. Studies were extracted if they included complete response (CR), complete control (CC), no nausea, no vomiting, and no rescue medications as an endpoint. Studies were also included if safety endpoints were examined. Results Palonosetron alone has been shown to improve CR and CC rates for patients receiving low, moderate, or high emetogenic chemotherapy. Rates were further improved with the addition of dexamethasone, a corticosteroid. Furthermore, the addition of neurokinin-1 receptor antagonists, such as netupitant markedly improved efficacy profiles compared to palonosetron alone. Aprepitant is an antiemetic that has exhibited positive results in combination with palonosetron. Recently, a new drug consisting of netupitant and palonosetron (NEPA) has demonstrated significantly more efficacious prevention of CINV. Regardless of the combination, palonosetron has been well tolerated. The most common adverse events were constipation, headache, fatigue, and dizziness, with the majority of patients describing them as only mild or moderate. Conclusion Palonosetron, alone or with other antiemetics, has improved CINV treatment due to its ability to significantly reduce delayed phases of CINV, compared to similar 5-HT3RAs. Palonosetron is both more effective than first generation 5-HT3RAs and safer, as it results in a smaller prolongation of the QTc interval, compared to other 5-HT3RAs.

The accuracy of clinicians’ predictions of survival in advanced cancer: a review

The process of formulating an accurate survival prediction is often difficult but important, as it influences the decisions of clinicians, patients, and their families. The current article aims to review the accuracy of clinicians predictions of survival (CPS) in advanced cancer patients. A literature search of Cochrane CENTRAL, EMBASE, and MEDLINE was conducted to identify studies that reported clinicians prediction of survival in advanced cancer patients. Studies were included if the subjects consisted of advanced cancer patients and the data reported on the ability of clinicians to predict survival, with both estimated and observed survival data present. Studies reporting on the ability of biological and molecular markers to predict survival were excluded. Fifteen studies that met the inclusion and exclusion criteria were identified. Clinicians in five studies underestimated patients survival (estimated to observed survival ratio between 0.5 and 0.92). In contrast, 12 studies reported clinicians overestimation of survival (ratio between 1.06 and 6). CPS in advanced cancer patients is often inaccurate and overestimated. Given these findings, clinicians should be aware of their tendency to be overoptimistic. Further investigation of predictive patient and clinician characteristics is warranted to improve clinicians ability to predict survival.

Inadequate pain management in cancer patients attending an outpatient palliative radiotherapy clinic

PurposeThe aim of this study is to assess the prevalence of undertreated cancer pain in an outpatient palliative radiotherapy clinic using the Pain Management Index (PMI).MethodsA retrospective analysis of a prospective database to assess pain management was done on patients with cancer pain enrolled from January 2009 to March 2015 using recorded pain intensity (0–10) and baseline pain medications. The pain intensities were categorized into no pain (0), mild pain (1), moderate pain (2), and severe pain (3), and an analgesic score was assigned to the most potent pain medication the patient was taking during the time of data collection. “0” was assigned to no analgesics, “1” to non-opioids, “2” to weak opioids, and “3” for strong opioids based on the WHO guidelines. The PMI was calculated for each patient by subtracting the pain score from the analgesic score. A negative value indicated undertreatment, and a value of 0 or greater corresponded to adequate pain management.ResultsThree hundred fifty-four patients were included in the study. The incidence of inadequate pain management was 33.3xa0%, similar to that reported in our previous studies. Additionally, 106 patients were taking strong opioids and reporting severe pain despite being the PMI reporting adequately treated.ConclusionThe rate of undertreatment is similar to that reported in past studies; however, the rates have shown a slight increase in our palliative radiotherapy clinic since the last assessment. Inadequate management of cancer pain continues to be a problem.

A prospective study of gastrointestinal radiation therapy-induced nausea and vomiting

ObjectiveNausea and vomiting are common side effects from radiotherapy that can interfere with gastrointestinal (GI) cancer patients’ quality of life (QOL). A prospective study among patients with GI cancers was conducted to document the timing, incidence and risk factors of radiation therapy-induced nausea and vomiting (RINV).MethodsForty-eight patients planned to receive curative or palliative intent abdominal and/or pelvic radiotherapy alone or with concomitant chemoradiotherapy were followed prospectively. All episodes of nausea, vomiting, retching and antiemetic use were recorded daily for the entire treatment period and for the week following completion of therapy. QOL was assessed weekly using the Functional Living Index—Emesis Quality of Life Tool and the EORTC QLQ-C30 core questionnaire.ResultsNausea occurred in 83xa0% of patients and emesis in 54xa0%. Pancreatic cancer was significantly correlated to higher proportions of nausea and emesis (pu2009=u20090.002 and pu2009=u20090.0003) compared to other primary sites. There were no significant difference between concomitant chemoradiotherapy and radiotherapy only patients for nausea and emesis. Patients had significantly greater proportions of RINV during the first, second and fifth weeks of treatment and during the first week following treatment. Vomiting was found to impair patients’ usual recreation or leisure activities and enjoyment of their meals. Worse physical, role and social functioning and greater fatigue and appetite loss over the course of treatment correlated directly with the timing of RINV symptoms.ConclusionRINV worsened QOL and was experienced even after treatment was completed; physicians should therefore be cognizant and monitor patients in the week following radiotherapy. Concomitant chemoradiotherapy should potentially be included in the moderate emetogenic risk category.

Quality of life and symptom burden in patients with breast cancer treated with mastectomy and lumpectomy

IntroductionMastectomy (MAS) and lumpectomy (LUMP) are the two common local surgical treatments for early breast cancer. There has been a debate whether MAS or LUMP results in better quality of life (QOL). The purpose of this study was to examine the symptom burden (SB) and QOL of both MAS and LUMP patients.MethodsPatients at the Louise Temerty Breast Cancer Centre in Toronto, Canada, were approached to complete two self-administered questionnaires, the Edmonton Symptom Assessment Score (ESAS) and the Functional Assessment of Cancer Therapy—Breast (FACT-B) cancer edition. Additionally, patient demographics were recorded from medical records. Patients were divided into two cohorts depending on their surgical treatment: MAS and LUMP. The QOL and SB, assessed by FACT-B and ESAS, respectively, of MAS and LUMP patients were compared. The analysis was repeated excluding patients with metastases.ResultsFrom January to August 2014, 614 MAS and 801 LUMP patients were accrued. The MAS patients reported a lower QOL in all categories, except social well-being. There was however no statistical difference in ESAS scores for MAS and LUMP patients with non-metastatic breast cancer.ConclusionThis study supports existing literature that SB of MAS and LUMP patients without metastases are similar. QOL of MAS patients including those with metastases was lower than that of LUMP patients.

Fatigue scores in patients with brain metastases receiving whole brain radiotherapy

PurposeWhole brain radiotherapy (WBRT) is a treatment strategy used commonly to relieve burdensome symptoms and improve quality of life (QOL) in patients with multiple brain metastases. The purpose of this study is to determine changes in fatigue score following WBRT as it is a common symptom experienced in this population.MethodsFatigue and overall QOL scores were collected prospectively in patients for up to 3xa0months post-WBRT by several questionnaires at different times including the following: Edmonton Symptom Assessment System (ESAS), Brain Symptom and Impact Questionnaire (BASIQ), Spitzer Questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), EORTC brain module (EORTC QLQ-BN20u2009+u20092), EORTC QLQ-C15-PAL, and Functional Assessment of Cancer Therapy—General (FACT-G). Questionnaires were grouped for analysis by Wilcoxon Signed Rank test according to the scale of ranking into 0–10, 1–4, and 0–4.ResultsThirty-six patients were interviewed with the ESAS or BASIQ. The median age was 65xa0years old, and median Karnofsky Performance Status (KPS) was 70. There was a significant increase in fatigue score from baseline to month 1 (pu2009=u20090.02), and months 2 and 3 had no significant change. There was a significant correlation between fatigue and overall QOL score at baseline and month 1 (pu2009=u20090.01, pu2009<u20090.0001), respectively. Two hundred and twenty-eight patients were surveyed with Spitzer, C15-PAL, BN20u2009+u20092, QLQ-C30, or FACT-G. Median age was 64xa0years old and median KPS was 80. Compared to baseline, fatigue score was significantly higher at month 1 (pu2009<u20090.0001) and month 2 (pu2009=u20090.001), with no significant change at month 3. Significant correlation was found between fatigue and overall QOL at baseline, months 1, 2 (pu2009<u20090.0001), and 3 (pu2009=u20090.0009). For all groups, there was no significant change in fatigue score between patients with or without dexamethasone (Dx), except for the fatigue changed score of the group with scale 0–4.ConclusionsFatigue was significantly increased from baseline to month 1 in all patients, and most patients experienced no difference in fatigue if they were receiving Dx. Increased fatigue was significantly related with decreased overall QOL.