SAR-096: Phase II Clinical Trial of Ribociclib in Combination with Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS).

PURPOSE: Dedifferentiated liposarcoma (DDL) and leiomyosarcoma (LMS) are two common subtypes of soft-tissue sarcoma, a rare group of diseases for which new treatments are needed. Chemotherapy remains the standard option for advanced disease. Targeting cyclin-dependent kinase 4 and 6 (CDK4/6) in DDL and mTOR in LMS is of biologic interest. When combined, the CDK4 inhibitor ribociclib and the mTOR inhibitor everolimus have shown synergistic growth inhibition in multiple tumor models, suggesting that this combination could be beneficial in patients. PATIENTS AND METHODS: This was a single arm, open label, multicenter phase II study of the combination of ribociclib and everolimus. Patients were enrolled into one of two cohorts: DDL or LMS with intact Rb. The primary endpoint was progression-free rate (PFR) at 16 weeks. Secondary endpoints included progression-free survival (PFS) and overall survival, safety and biomarker analyses. RESULTS: In the DDL cohort, 33.3% [95% confidence interval (CI), 15.6%-55.3%] of patients were progression-free at 16 weeks. Median PFS in this cohort was 15.4 weeks (95% CI, 8-36 weeks) with 2 partial responses. In the LMS cohort the PFR at 16 weeks was 29.2% (95% CI, 12.6%-51.1%). Median PFS in this cohort was 15.7 weeks (95% CI, 7.7-NA). Most common toxicities included fatigue (66.7%), anorexia (43.8%), and hyperglycemia (43.8%). Concordance between Rb testing methodologies was poor. CONCLUSIONS: The combination of ribociclib and everolimus demonstrates activity in DDL with prolonged stable disease (≥16 weeks) meeting the primary endpoint. Notably partial responses were observed. The primary endpoint was not reached in the LMS cohort. The combination was well tolerated with expected side effects.

Team-Based Care in Oncology: The Impact of the Advanced Practice Provider.

Integration of APPs into care teams affects quality and safety for the oncology patient. Learn the best practices and understand the concepts of onboarding, orientation, mentorship, scope of practice, and top of license. Review how productivity and other incentive programs can be adapted to integrate APPs and focus on team-based metrics.

Moral Distress, Organizational Climate, and the Risk of Burnout Among Physician Assistants in Oncology.

PURPOSE: Moral distress (MD) is the result of barriers or constraints that prevent providers from carrying out what they believe to be ethically appropriate care. This study was initiated to explore associations between MD, burnout, and the organizational climate (OC) for oncology physician assistants (PAs). METHODS: A national survey of oncology PAs was conducted to explore the associations between MD, OC, and burnout. The Nurse Practitioner-Primary Care OC Questionnaire was revised for oncology PAs to assess OC for PA practice. MD and burnout were assessed using the Measure of MD-Healthcare Professionals (MMD-HP) and the Maslach Burnout Inventory. RESULTS: One hundred forty-six oncology PAs are included in the analysis. PAs were mostly female (90%), White/Caucasian (84%), married/partnered (78%), and in medical oncology (73%), with mean age 41.0 years. The mean MMD-HP score for oncology PAs was 71.5 and there was no difference in MD scores on the basis of oncology subspecialty, practice setting, practice type, or hours worked per week. PAs currently considering leaving their position because of MD had significantly higher mean scores on the MMD-HP compared with those not considering leaving their position (108.2 v 64.8; P = .001). PAs with burnout also had significantly higher mean scores for MD compared with PAs without burnout (97.6 v 54.3; P < .001). A negative relationship between OC for PA practice and MD was only found for the PA-administration relations subscale, whereas all subscales were negatively associated with burnout. CONCLUSION: This study demonstrates that the risk of professional burnout increases significantly with increasing levels of MD. Additional research exploring the relationship between MD and burnout is needed.

OER-073: A multicenter phase 2 study evaluating the role of pazopanib in angiosarcoma.

BACKGROUND: Angiosarcomas are rare mesenchymal sarcomas that can present as primary cutaneous or noncutaneous disease. They express a variety of vascular endothelial growth factor receptors. The authors hypothesized that the treatment of angiosarcoma with pazopanib, a multikinase inhibitor with activity against vascular endothelial growth factor receptors, would result in disease response and prolonged disease stabilization. METHODS: This was an open-label, phase 2 trial of pazopanib in patients who had incurable angiosarcoma. The co-primary end points were response according to the Response Evaluation Criteria in Solid Tumors and progression-free survival (PFS) at 3 months. The starting dose of pazopanib was 800 mg daily. RESULTS: Twenty-nine patients were accrued between 2011 and 2018, and 22 patients were evaluable for response. Toxicities were similar to those identified in prior reports. There was one partial response (3%), and the clinical benefit rate (including complete responses, partial responses, and stable disease) was 48%, which was observed more frequently in patients who had cutaneous disease. The median PFS was 14.4 weeks, and the 3-month PFS rate determined by Kaplan-Meier estimate was 54.6% (95% CI, 36.0%-82.9%), meeting the primary study objective. The Kaplan-Meier overall survival estimate was 16.1 months. CONCLUSIONS: Pazopanib therapy in patients who had incurable angiosarcoma was associated with meaningful disease control, especially in those who had cutaneous disease with limited objective responses. LAY SUMMARY: Angiosarcoma is a rare cancer that can be found on the skin or in internal organs. This study tested pazopanib, an oral targeted medication, to determine its benefit in patients with angiosarcoma who could not undergo the removal of their tumors by surgery. Pazopanib treatment was safe, and no new side effects were reported. The study showed that pazopanib controlled tumor growth in one half of patients at 3 months and was more common in angiosarcomas of the skin; it led to tumor shrinkage in a minority of patients (1 of 29).

Association of Organizational Context, Collaborative Practice Models, and Burnout Among Physician Assistants in Oncology.

PURPOSE: Despite an increase in the number of physician assistants (PAs) in the oncology workforce, their potential to meet anticipated demand for oncology services may be hindered by high rates of burnout. The aim of this study was to examine the association between organizational context (OC) and burnout among oncology PAs to better understand factors associated with burnout. METHODS: A national survey of oncology PAs was conducted to explore relationships between burnout and the OC in which the PA practiced. The Areas of Worklife Survey (AWS) assessed OC by examining six key workplace qualities (workload, control, reward, community, fairness, and values). Burnout was assessed using the Maslach Burnout Inventory. RESULTS: PAs demonstrating burnout scored significantly lower across all domains of the AWS than those without burnout (P < .001 for each AWS subscale). The median score for each domain of the AWS and burnout (No v Yes) were as follows: workload (3.33 v 2.67), control (3.67 v 3.00), reward (4.00 v 3.67), community (4.00 v 3.67), fairness (3.33 v 2.67), and values (4.00 v 3.33). Multivariable analysis found that mismatches between the PA and their work environment in workload (odds ratio [OR] = 1.99; 95% CI, 1.32 to 3.02; P = .001), reward (OR = 1.89, 95% CI, 1.18 to 3.02; P = .008), and values (OR = 2.25; 95% CI, 1.31 to 3.88; P = .003) were more likely to report burnout. Differences in burnout in the context of workload were not explained by patient volume, practice structure, or professional autonomy. CONCLUSION: Workload, reward, and values were associated with greater odds of burnout, with workload being the most common mismatch in job fit. Sustainable workloads and consistency in rewards (financial, institutional, and social) for oncology PAs should be an employer's focus to help mitigate their risk of burnout.

Changes in Burnout Among Oncology Physician Assistants Between 2015 and 2019.

PURPOSE: Burnout has significant implications for the individual provider, the oncology workforce, and the quality of care for patients with cancer. The primary aim of this study was to explore temporal changes in burnout among physician assistants (PAs) in oncology in 2019 compared with 2015. METHODS: Oncology PAs were surveyed to assess for burnout using the Maslach Burnout Inventory according to the same cross-sectional design of the study performed in 2015. Comparison between oncology PAs in 2015 and 2019 in the prevalence of burnout and personal and professional characteristics was performed. RESULTS: Two hundred thirty-four participants completed the full-length survey. The participants in 2015 and 2019 were similar in age (41.8 v 40.3 years), sex (88.8% v 86.3% female), number of years as a PA in oncology (9.6 v 10), and percentage involved in academic practice (55.2% v 59.2%). There was a significant increase in burnout in 2019 compared with 2015 with 48.7% of PAs reporting at least one symptom of burnout compared with 34.8% (odds ratio for burnout, 2019 v 2015 = 1.92 [95% CI, 1.40 to 2.65], P < 0.001). The odds of burnout remained higher in 2019 compared with 2015 when adjusted for age, sex, relationship status, practice setting, subspecialty, practice type, and hours worked. Factors associated with burnout in both 2015 and 2019 include the percentage of time spent on patient care, collaborative physician relationship, number of hours worked, and satisfaction with compensation. No new factors associated with burnout emerged in 2019 that were not identified in 2015. CONCLUSION: The rate of burnout of oncology PAs has significantly increased. Burnout in oncology PAs is multifactorial, and the increase cannot be easily explained. Additional research is needed to better define the drivers of PA burnout.

Creating a Blueprint of Well-Being in Oncology: An Approach for Addressing Burnout From ASCO's Clinician Well-Being Taskforce.

Optimizing the well-being of the oncology clinician has never been more important. Well-being is a critical priority for the cancer organization because burnout adversely impacts the quality of care, patient satisfaction, the workforce, and overall practice success. To date, 45% of U.S. ASCO member medical oncologists report experiencing burnout symptoms of emotional exhaustion and depersonalization. As the COVID-19 pandemic remains widespread with periods of outbreaks, recovery, and response with substantial personal and professional consequences for the clinician, it is imperative that the oncologist, team, and organization gain direct access to resources addressing burnout. In response, the Clinician Well-Being Task Force was created to improve the quality, safety, and value of cancer care by enhancing oncology clinician well-being and practice sustainability. Well-being is an integrative concept that characterizes quality of life and encompasses an individual's work- and personal health-related environmental, organizational, and psychosocial factors. These resources can be useful for the cancer organization to develop a well-being blueprint: a detailed start plan with recognized strategies and interventions targeting all oncology stakeholders to support a culture of community in oncology.

Optimal Avapritinib Treatment Strategies for Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.

BACKGROUND: Avapritinib, a novel inhibitor of KIT/PDGFRA, is approved in the U.S. for the treatment of adults with PDGFRA exon 18-mutant unresectable or metastatic gastrointestinal stromal tumors (U/M GISTs). We assessed the safety of avapritinib and provide evidence-based guidance on management of avapritinib-associated adverse events (AEs), including cognitive effects and intracranial bleeding. MATERIALS AND METHODS: We performed a post hoc analysis of data from a two-part, single-arm dose escalation/expansion phase I study (NAVIGATOR; NCT02508532) in patients with U/M GISTs treated with oral avapritinib 30-600 mg once daily. The primary endpoints were safety and tolerability; the impact of dose modification (interruption and/or reduction) on progression-free survival (PFS) was a secondary endpoint. Efficacy analyses were limited to patients who started avapritinib at 300 mg (approved dose). RESULTS: Of 250 patients enrolled in the study, 74.0% presented with KIT mutation and 24.8% presented with PDGFRA exon 18-mutation; 66.8% started avapritinib at 300 mg. The most common treatment-related AEs (any grade) were nausea (59.2%), fatigue (50.0%), periorbital edema (42.0%), anemia (39.2%), diarrhea (36.0%), vomiting (36.0%), and increased lacrimation (30.8%). No treatment-related deaths occurred. Among 167 patients starting on 300 mg avapritinib, all-cause cognitive effects rate (grade 1-2) was 37.0% in all patients and 52.0% in patients ≥65 years. Cognitive effects improved to a lower grade more quickly with dose modification (1.3-3.1 weeks) than without (4.9-7.6 weeks). Median PFS was 11.4 months with dose modification and 7.2 months without. CONCLUSION: Tolerability-guided dose modification of avapritinib is an effective strategy for managing AEs in patients with GISTs. IMPLICATIONS FOR PRACTICE: Early recognition of adverse events and tailored dose modification appear to be effective approaches for managing treatment-related adverse events and maintaining patients on avapritinib. Dose reduction does not appear to result in reduced efficacy. Patients' cognitive function should be assessed at baseline and monitored carefully throughout treatment with avapritinib for the onset of cognitive adverse events. Dose interruption is recommended at the first sign of any cognitive effect, including grade 1 events.

A Call to Action: Ethics Committee Roundtable Recommendations for Addressing Burnout and Moral Distress in Oncology.

Oncologist well-being is critical to initiating and maintaining the physician-patient relationship, yet many oncologists suffer from symptoms of burnout. Burnout has been linked to poor physical and mental health, as well as increased medical errors, patient dissatisfaction, and workforce attrition. In this Call to Action article, we discuss causes of and interventions for burnout and moral distress in oncology, highlight existing interventions, and provide recommendations for addressing burnout and improving well-being at the individual and organizational levels to deliver ethical, quality cancer care.

Understanding the role of advanced practice providers in oncology in the United States.

PURPOSE: Advanced practice providers (APPs, which include NPs and physician assistants [PAs]) are integral members of oncology teams. This study aims first to identify all APPs in oncology and, second, to understand personal and practice characteristics (including compensation) of those APPs. METHODS: We identified APPs who practice oncology from membership and claims data. We surveyed 3,055 APPs about their roles in clinical care. RESULTS: We identified at least 5,350 APPs in oncology and an additional 5,400 who might practice oncology. Survey respondents totaled 577 out of 3,055, which provided a 19% response rate. Results focused on 540 NPs and PAs. Greater than 90% reported satisfaction with career choice. Respondents identified predominately as white (89%) and female (94%). NPs and PAs spent the majority (80%) of time in direct patient care. The top four patient care activities were patient counseling (NPs, 94%; PAs, 98%), prescribing (NPs, 93%; PAs, 97%), treatment management (NPs, 89%; PAs, 93%), and follow-up visits (NPs, 81%; PAs, 86%). A majority of all APPs reported both independent and shared visits (65% hematology/oncology/survivorship/prevention/pediatric hematology/oncology; 85% surgical/gynecologic oncology; 78% radiation oncology). A minority of APPs reported that they conducted only shared visits. Average annual compensation was between $113,000 and $115,000, which is about $10,000 higher than average pay for APPs not in oncology. CONCLUSION: We identified 5,350 APPs in oncology and conclude that number may be as high as 7,000. Survey results suggest that practices that incorporate APPs routinely rely on them for patient care. Given the increasing number of patients with and survivors of cancer, APPs are important to ensure access to quality cancer care now and in the future.

Understanding the Role of Advanced Practice Providers in Oncology in the United States.

PURPOSE: Advanced practice providers (APPs, which include nurse practitioners [NPs] and physician assistants [PAs]) are integral members of oncology teams. This study aims to identify all oncology APPs and to understand personal and practice characteristics (including compensation) of those APPs. METHODS: We identified APPs who practice oncology from membership and claims data. We surveyed 3,055 APPs about their roles in clinical care. RESULTS: We identified at least 5,350 APPs in oncology and an additional 5,400 who might practice oncology. Survey respondents totaled 577, which provided a 19% response rate. Results focused on 540 NPs and PAs. Greater than 90% reported satisfaction with career choice. Respondents identified predominately as White (89%) and female (94%). NPs and PAs spent the majority (80%) of time in direct patient care. The top four patient care activities were patient counseling (NPs = 94%; PAs = 98%), prescribing (NPs = 93%; PAs = 97%), treatment management (NPs = 89%; PAs = 93%), and follow-up visits (NPs = 81%; PAs = 86%). A majority of all APPs reported both independent and shared visits (65% hematology/oncology/survivorship/prevention/pediatric hematology/oncology; 85% surgical/gynecologic oncology; 78% radiation oncology). A minority of APPs reported that they conducted only shared visits. Average annual compensation was between $113,000 and $115,000, which is approximately $10,000 higher than average pay for nononcology APPs. CONCLUSION: We identified 5,350 oncology APPs and conclude that number may be as high as 7,000. Results suggest that practices that incorporate APPs routinely rely on them for patient care. Given the increasing number of patients with and survivors of cancer, APPs are important to ensure access to quality cancer care.

Understanding the Role of Advanced Practice Providers in Oncology in the United States.

PURPOSE: Advanced practice providers (APPs, which include nurse practitioners [NPs] and physician assistants [PAs]) are integral members of oncology teams. This study aims first to identify all oncology APPs and, second, to understand personal and practice characteristics (including compensation) of those APPs. METHODS: We identified APPs who practice oncology from membership and claims data. We surveyed 3,055 APPs about their roles in clinical care. RESULTS: We identified at least 5,350 APPs in oncology and an additional 5,400 who might practice oncology. Survey respondents totaled 577, which provided a 19% response rate. Results focused on 540 NPs and PAs. Greater than 90% reported satisfaction with career choice. Respondents identified predominately as white (89%) and female (94%). NPs and PAs spent the majority (80%) of time in direct patient care. The top four patient care activities were patient counseling (NPs, 94%; PAs, 98%), prescribing (NPs, 93%; PAs, 97%), treatment management (NPs, 89%; PAs, 93%), and follow-up visits (NPs, 81%; PAs, 86%). A majority of all APPs reported both independent and shared visits (65% hematology/oncology/survivorship/prevention/pediatric hematology/oncology; 85% surgical/gynecologic oncology; 78% radiation oncology). A minority of APPs reported that they conducted only shared visits. Average annual compensation was between $113,000 and $115,000, which is approximately $10,000 higher than average pay for nononcology APPs. CONCLUSION: We identified 5,350 oncology APPs and conclude that number may be as high as 7,000. Survey results suggest that practices that incorporate APPs routinely rely on them for patient care. Given the increasing number of patients with and survivors of cancer, APPs are important to ensure access to quality cancer care now and in the future.

National Study of Burnout and Career Satisfaction Among Physician Assistants in Oncology: Implications for Team-Based Care.

PURPOSE: A high rate of burnout has been reported in oncology physicians. Physician assistants (PAs) may also face similar risks of burnout. We sought to measure the personal and professional characteristics associated with burnout and career satisfaction and the potential impact on the oncology PA workforce. PARTICIPANTS AND METHODS: A national survey of PAs in oncology was completed by using the Maslach Burnout Inventory from September 2015 to January 2016. RESULTS: In all, 855 PAs were contacted and 250 submitted complete surveys (response rate, 29.2%). Respondents were representative of PAs in oncology with a mean age of 41.8 years, females (88.8%), academic practice (55.2%), urban location (61.2%), outpatient (74.4%), medical oncology (75.2%), worked 41 to 50 hours per week (52.8%), and had a mean of 9.6 years as a PA in oncology. Burnout was reported in 34.8% of PAs, 30.4% reported high emotional exhaustion, 17.6% reported high depersonalization, and 19.6% reported a low sense of personal accomplishment. In multivariable analysis, age, time spent on indirect patient care, oncology subspecialty, and relationship with collaborating physician were factors associated with burnout. Career and specialty satisfaction was high (86.4% and 88.8%, respectively). In the next 2 years, only 3.6% of PAs plan to pursue a different career or specialty and only 2.0% plan to retire. CONCLUSION: Despite high career and specialty satisfaction, burnout is reported in one third of PAs in oncology. Further exploration of the relationship between PAs and collaborating physicians may provide insight on methods to decrease burnout. Negligible short-term attrition of the current oncology PA workforce is anticipated.

Understanding the Role of Advanced Practice Providers in Oncology in the United States.

Purpose: Advanced practice providers (APPs, which include nurse practitioners [NPs] and physician assistants [PAs]) are integral members of oncology teams. This study aims first to identify all oncology APPs and, second, to understand personal and practice characteristics (including compensation) of those APPs. Methods: We identified APPs who practice oncology from membership and claims data. We surveyed 3,055 APPs about their roles in clinical care. Results: We identified at least 5,350 APPs in oncology and an additional 5,400 who might practice oncology. Survey respondents totaled 577, which provided a 19% response rate. Results focused on 540 NPs and PAs. Greater than 90% reported satisfaction with career choice. Respondents identified predominately as white (89%) and female (94%). NPs and PAs spent the majority (80%) of time in direct patient care. The top four patient care activities were patient counseling (NPs, 94%; PAs, 98%), prescribing (NPs, 93%; PAs, 97%), treatment management (NPs, 89%; PAs, 93%), and follow-up visits (NPs, 81%; PAs, 86%). A majority of all APPs reported both independent and shared visits (65% hematology/ oncology/survivorship/prevention/pediatric hematology/oncology; 85% surgical/ gynecologic oncology; 78% radiation oncology). A minority of APPs reported that they conducted only shared visits. Average annual compensation was between $113,000 and $115,000, which is approximately $10,000 higher than average pay for nononcology APPs. Conclusion: We identified 5,350 oncology APPs and conclude that number may be as high as 7,000. Survey results suggest that practices that incorporate APPs routinely rely on them for patient care. Given the increasing number of patients with and survivors of cancer, APPs are important to ensure access to quality cancer care now and in the future.

Clinical oncology practice 2015: preparing for the future.

The clinical practice of oncology has become increasingly complex. An explosion of medical knowledge, increased demands on provider time, and involved patients have changed the way many oncologists practice. What was an acceptable practice model in the past may now be relatively inefficient. This review covers three areas that address these changes. The American Society of Clinical Oncology (ASCO) National Oncology Census defines who the U.S. oncology community is, and their perceptions of how practice patterns may be changing. The National Cancer Institute (NCI)-ASCO Teams in Cancer Care Project explores how best to employ team science to improve the efficiency and quality of cancer care in the United States. Finally, how physician assistants (PAs) and nurse practitioners (NPs) might be best integrated into team-based care in oncology and the barriers to integration are reviewed.

Peripheral primitive neuroectodermal tumor of the dura in a 51-year-old woman following intensive treatment for breast cancer.

PATIENT: Female, 51. FINAL DIAGNOSIS: Ewing sarcoma. SYMPTOMS: Visual disturbances. MEDICATION: -. CLINICAL PROCEDURE: -. SPECIALTY: Oncology. OBJECTIVE: Rare disease. BACKGROUND: Primitive neuroectodermal tumor/Ewing sarcoma (PNET/EWS) is a round blue cell sarcoma that shows varying degrees of neuroectodermal differentiation. PNET/EWS as a primary intracranial tumor is extremely uncommon. CASE REPORT: We report a unique case of peripheral PNET presenting as an intracranial mass in an adult following chemotherapy and radiotherapy for a solid tumor. A 51-year-old woman with previously treated left breast cancer was evaluated for a newly developed brain mass. She underwent craniotomy with resection. Surgical pathology was consistent with a peripheral PNET/EWS with Ewing sarcoma gene translocation. She was treated appropriately with vincristine, cyclophosphamide, and doxorubicin (later dactinomycin) alternating with ifosfamide and etoposide. CONCLUSIONS: Although development of PNET/EWS presenting along the CNS is exceedingly rare in adults, establishing the proper diagnosis of this "small blue cell tumor" is critical. The further distinction between central PNET and peripheral PNET can greatly impact both prognosis and treatment. Our case also highlights the importance of considering the impact of prior intensive therapies, including radiation and chemotherapy, on predisposing to future PNET/EWS.

Optimizing adherence to adjuvant imatinib in gastrointestinal stromal tumor.

The increasing use of patient-administered oral anticancer drugs is paralleled by new challenges in maintaining treatment adherence. These challenges are particularly significant with adjuvant therapies for prevention of disease recurrence, where the benefits of ongoing treatment are not readily apparent to patients. Nurse practitioners and physician assistants (collectively referred to as advanced practitioners) play integral roles in providing education on disease and treatment to patients that can increase adherence to oral therapies and ideally improve outcomes. For patients with gastrointestinal stromal tumor (GIST), the oral targeted therapy imatinib has become the mainstay of treatment for advanced and recurrent disease and as adjuvant therapy following surgical resection. Recent data indicate significantly improved overall survival with 3 years vs. 1 year of adjuvant imatinib therapy. Continuous dosing with imatinib is needed for optimal efficacy and to limit additional health-care costs associated with management of disease progression in GIST. However, longer duration of therapy increases the risk of nonadherence. Imatinib adherence rates, as well as factors contributing to nonadherence to adjuvant therapy in routine clinical practice, are discussed in this review. Also explored are practical approaches for improving adherence to adjuvant imatinib therapy through greater patient education, in light of the increased duration of therapy in select patients.

Contribution of capecitabine for therapy of patients with gastroesophageal cancer: an update of recent phase III results.

BACKGROUND: Capecitabine, an orally administered fluoropyrimidines, is widely used in the treatment of multiple malignancies. It has been extensively evaluated in patients with gastroesophageal carcinoma. Since recent reviews have discussed phase I/II trials (Cancer 107:221-231, 2006; Drugs 67:601-610, 2007), we focus on the impact of the results of the most current phase III trials using capectiabine in the treatment of advanced gastroesophageal cancers, primarily in the first-line setting. METHODS: To find published phase III trials, Medline was searched for English-language clinical trials published from 1996 through June 2007 along with relevant abstracts presented at the American Society of Clinical Oncology, and meetings of the European Cancer Conference and European Society of Medical Oncology. Only representative trials were chosen for this manuscript. RESULTS: The most frequently investigated combinations are capecitabine with taxanes, platinols, and camptothecins. Recent results of a large phase III trial (REAL-2) in untreated patients with gastroesophageal cancer suggest that capecitabine is a non-inferior substitute for intravenous 5-fluorouracil. These results of REAL-2 trial are substantiated by a smaller phase III trial. Previous analysis of multiple trials had suggested that capecitabine, when combined in doses lower than 1250 mg/m(2) twice daily, consistently resulted in lower frequency of Grade 3 or 4 toxic effects. CONCLUSIONS: Capecitabine provides much needed convenience to patients with gastroesophageal cancer. The recent data derived from two phase III trials confirm that capecitabine is a suitable substitute for intravenous 5-fluorouracil in patients whose swallowing is not greatly affected. Capecitabine remains a subject of further investigations in this group of patients with interest.

Emerging drugs in the treatment of advanced gastric cancer.

BACKGROUND: Gastroesopheal cancer is one of the most common cancers worldwide. If detected early, curative treatment is possible. Often, gastroesophageal cancer is detected at an advanced stage when therapy is palliative. OBJECTIVES: To provide a critical evaluation of historic and recently developed chemotherapy regimens for the treatment of advanced gastroesophageal cancer (AGC). METHODS: Published clinical trials in AGC as well as selected abstracts presented at international oncology meetings were selected. RESULTS/CONCLUSION: Chemotherapy has demonstrated a benefit over best supportive care alone by improving the quality and quantity of life for patients with advanced disease. Recent Phase III trials investigating cytotoxic chemotherapy and Phase II trials incorporating biotherapy for the treatment of AGC show promise for the future.