The Oncologist

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ISSN / EISSN : 1083-7159 / 1549-490X
Current Publisher: Wiley (10.1002)
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, Espérance Mutoniwase Ba, Cam Nguyen, Anita Ho, Grace Umutesi, Eugene Nkusi, Fidele Sebahungu, , , Cyprien Shyirambere
Published: 10 May 2021
by Wiley
The Oncologist; doi:10.1002/onco.13818

Abstract:
Background Moral distress and burnout are highly prevalent among oncology clinicians. Research is needed to better understand how resource constraints and systemic inequalities contribute to moral distress in order to develop effective mitigation strategies. Oncology providers in low‐ and middle‐income countries (LMICs) are well positioned to provide insight into the moral experience of cancer care priority setting and expertise to guide solutions. Methods Semi‐structured interviews were conducted with a purposive sample of 22 oncology physicians, nurses, program leaders, and clinical advisors at a cancer center in Rwanda. Interviews were recorded, transcribed verbatim, and analyzed using the framework method. Results Participants identified sources of moral distress at three levels of engagement with resource prioritization: witnessing program‐level resource constraints drive cancer disparities, implementing priority setting decisions into care of individual patients, and communicating with patients directly about resource prioritization implications. They recommended individual and organizational level interventions to foster resilience, such as communication skills training and mental health support for clinicians, interdisciplinary team‐building, fair procedures for priority setting, and collective advocacy for resource expansion and equity. Conclusion This study adds to the current literature an in‐depth examination of the impact of resource constraints and inequities on clinicians in a low resource setting. Effective interventions are urgently needed to address moral distress, reduce clinician burnout, and promote well‐being among a critical but strained oncology workforce. Collective advocacy is concomitantly needed to address the structural forces that constrain resources unevenly and perpetuate disparities in cancer care and outcomes. Implications for Practice For many oncology clinicians worldwide, resource limitations constrain routine clinical practice and necessitate decisions about prioritizing cancer care. To our knowledge, this study is the first in‐depth analysis of how resource constraints and priority setting lead to moral distress among oncology clinicians in a low resource setting. Effective individual and organizational interventions and collective advocacy for equity in cancer care are urgently needed to address moral distress and reduce clinician burnout among a strained global oncology workforce. Lessons from low resource settings can be gleaned as high‐income countries face growing needs to prioritize oncology resources.
H Teerenhovi, S Tuominen, S Nurmi‐Rantala, P Hemmilä,
Published: 6 May 2021
by Wiley
The Oncologist; doi:10.1002/onco.13813

Abstract:
Background Comparing breast cancer survival trends globally, Finland is among the top three countries in Europe. However, outcome data on breast cancer subgroups in the Finnish population is limited. This retrospective registry‐based study aimed to assess patient characteristics and clinical outcomes of different breast cancer subgroups in early (EBC) and metastatic breast cancer (MBC) in a real‐life clinical setting. Patients and Methods The study consisted of 6977 adult female breast cancer patients diagnosed in Southwest Finland during 2005‐2018. Patients were divided into four mutually exclusive groups: human epidermal growth factor receptor 2 positive (HER2+), triple negative, HER2‐/hormone receptor positive (HR+), and HER2 and/or HR status unknown, and further into EBC and MBC patients. Real‐world (rw) clinical outcomes: disease free survival (rwDFS), progression free survival (rwPFS), overall survival (OS) and distant recurrence‐free interval (rwDRFI) were assessed. Results Within EBC 5‐year survival was the highest 88% in HER2‐/HR+, 85% in HER2+, and 75% in triple negative. The rwDFS varied significantly in EBC (5‐year rwDFS HER2+, triple negative, HER2‐/HR+: 80%, 71%, 87% respectively). In MBC median survival was 2 years for both HER2‐/HR+ and HER2+, and markedly shorter for triple negative (0.8 years). Independent predictors of mortality were age (HR 1.1), other subgroups than HER2‐/HR+ (HR 1.2‐1.9), metastatic disease (HR 9.8), and other malignancies (HR 2.7). Conclusions This registry‐based study demonstrates significant differences in breast cancer outcomes on the subgroup level, as well as poorer outcomes compared to clinical trials, giving complementary insight on clinical characteristics in an unselected patient population. Implications for practise This retrospective registry‐based study assessed the clinical outcomes of different breast cancer subgroups in 6977 adult female breast cancer patients diagnosed in Southwest Finland during 2005‐2018. Results demonstrated significant variation in the survival between subgroups in both EBC and MBC, as well as differences between unselected patients representing the standard of care and randomized clinical trials. Although, according to the global comparison of survival trends, the net survival of breast cancer patients in Finland is generally high, there is great variation between subgroups. This real‐life breast cancer data provides tools to further evaluate medical need in different breast cancer subgroups.
Li‐Chun Chang Md, Chia‐Tung Shun Md, Been‐Ren Lin Md, Silvia Sanduleanu Md, Weng‐Feng Hsu Md, Ming‐Shiang Wu Md,
Published: 6 May 2021
by Wiley
The Oncologist; doi:10.1002/onco.13815

Abstract:
Background With the implementation of screening program worldwide, diagnosis of early‐stage colorectal cancer steadily increased, including T1 cancer. Current T1 cancer treatment does not differ according to anatomic location. We therefore compared the disease‐free survival of T1 cancer arising from rectum versus colon. Methods The hospital‐based study included subjects with T1 cancer at National Taiwan University Hospital from 2005 to 2014. Clinical, colonoscopy, and histopathology were reviewed for patients with a mean follow‐up time of 7.1 (0.7‐12.9) years. We conducted Kaplan‐Meier analysis to compare the risk of recurrence by cancer location and Cox‐regression analysis to identify risk factors for T1 cancer recurrence. Results The final cohort included a total of 343 subjects with T1 cancer (mean age, 64.9 ± 11.7 years; 56.1% males), of whom 25 underwent endoscopic resection alone. Of the subjects who underwent surgery, 50 had lymph node metastasis and 268 did not. Kaplan‐Meier analysis showed that the risk of recurrence was higher in T1 rectal cancer than T1 colon cancer (p =0.022). Rectal location, and larger neoplasm size were independent risk factors for recurrence, with hazard ratios (95% confidence interval) of 4.84 (1.18‐19.92), and 1.32 (1.06‐1.65), respectively. The occurrence of advanced histology did not differ between T1 rectal and colon cancers (p = 0.58). Conclusion T1 cancers arising from the rectum had less favorable recurrence outcomes than those arising from the colon. Further studies are needed to examine whether adjuvant radiotherapy or chemotherapy can reduce the risk of recurrence in T1 rectal cancer. Implications for Practice Current T1 colorectal cancer treatment and surveillance do not differ according to anatomic location. Clinical, colonoscopy, and histopathology were reviewed for 343 T1 cancer patients with a mean follow‐up time of 7.1 years. Kaplan‐Meier analysis showed that the risk of recurrence was higher in T1 rectal cancer than T1 colon cancer. Moreover, the rectal location was an independent risk factor for recurrence. T1 cancers from the rectum had less favorable recurrence outcomes than those arising from the colon. It is critical to clarify whether adjuvant therapy or more close surveillance can reduce recurrence risk in T1 rectal cancer.
, Olalekan Olasehinde, Debra A. Goldman Ms, Olusegun I. Alatise, Jeremy Constable Ba, Ngozi Monu, Gregory C. Knapp, Oluwole Odujoko, Emmanuella Onabanjo, Adewale O. Adisa, et al.
Published: 6 May 2021
by Wiley
The Oncologist; doi:10.1002/onco.13814

Abstract:
BACKGROUND Neoadjuvant chemotherapy (NAC) is an integral component of T4 breast cancer (BCa) treatment. We compared response to NAC for T4 BCa in the U.S. and Nigeria to direct future interventions. MATERIALS AND METHODS Cross‐sectional retrospective analysis included all non‐metastatic T4 BCa patients treated from 2010‐2016 at Memorial Sloan Kettering Cancer Center (New York, U.S.) and Obafemi Awolowo University Teaching Hospitals Complex (Ile Ife, Nigeria). Pathologic complete response (pCR) and survival were compared and factors contributing to disparities evaluated. RESULTS 308 patients met inclusion criteria: 157 (51%) in the U.S. and 151 (49%) in Nigeria. All U.S. patients received NAC and surgery compared with 93 (62%) Nigerian patients. 56/93 (60%) Nigerian patients completed their prescribed course of NAC. In Nigeria, older age and higher socioeconomic status were associated with treatment receipt. Fewer patients in Nigeria had immunohistochemistry performed (100% U.S. vs. 18% Nigeria). Of those with available receptor subtype, 18% (28/157) of U.S. patients were triple negative vs. 39% (9/23) of Nigerian patients. Overall pCR was seen in 27% (42/155) of U.S. patients and 5% (4/76) of Nigerian patients. Five‐year survival was significantly shorter in Nigeria vs. the U.S. (61% vs. 72%). However, among the subset of patients who received multimodality therapy, including NAC and surgery with curative intent, 5‐year survival (67% vs. 72%) and 5‐year recurrence‐free survival (48% vs. 61%) did not significantly differ between countries. CONCLUSION Addressing health system, socioeconomic, and psychosocial barriers is necessary for administration of complete NAC to improve BCa outcomes in Nigeria. Implications for Practice This cross‐sectional retrospective analysis of T4 breast cancer patients in Nigeria and the U.S. found a significant difference in pathologic complete response to neoadjuvant chemotherapy (5% Nigeria vs. 27% U.S.). Five‐year survival was shorter in Nigeria, but in patients receiving multimodality treatment, including neoadjuvant chemotherapy and surgery with curative intent, 5‐year overall and recurrence‐free survival did not differ between countries. Capacity‐building efforts in Nigeria should focus on access to pathology services to direct systemic therapy, and promoting receipt of complete chemotherapy to improve outcomes.
, Yoshiko Umeyama, Yuan Liu, Zhe Zhang, Patrick Schnell, Yuko Mori, Olivia Fletcher, Jean‐Claude Marshall, Jillian G. Johnson, Linda S. Wood, et al.
Published: 5 May 2021
by Wiley
The Oncologist; doi:10.1002/onco.13811

Abstract:
Background The most frequently reported treatment‐related adverse event in clinical trials with the cyclin‐dependent kinase 4/6 (CDK4/6) inhibitor palbociclib is neutropenia. Allelic variants in ABCB1 and ERCC1 might be associated with early occurrence (ie, end of Week 2 treatment) of grade 3/4 neutropenia. Pharmacogenetic analyses were performed to uncover associations between single nucleotide polymorphisms (SNPs) in these genes, patient baseline characteristics, and early occurrence of grade 3/4 neutropenia. Materials and Methods ABCB1 (rs1045642, rs1128503) and ERCC1 (rs3212986, rs11615) were analyzed in germline DNA from palbociclib‐treated patients from PALOMA‐2 (n=584) and PALOMA‐3 (n=442). SNP, race, and Cycle 1 Day 15 (C1D15) absolute neutrophil count (ANC) data were available for 652 patients. Univariate and multivariable analyses evaluated associations between SNPs, patient baseline characteristics, and early occurrence of grade 3/4 neutropenia. Analyses were stratified by Asian (n=122) and non‐Asian (n=530) ethnicity. Median progression‐free survival (mPFS) was estimated using the Kaplan‐Meier method. The effect of genetic variants on palbociclib pharmacokinetics was analyzed. Results ABCB1 and ERCC1_rs11615 SNP frequencies differed between Asian and non‐Asian patients. Multivariable analysis showed that low baseline ANC was a strong independent risk factor for C1D15 grade 3/4 neutropenia regardless of race (Asians: odds ratio [OR]=6.033, 95% CI=2.615−13.922, P<0.0001; Non‐Asians: OR=6.884, 95% CI=4.138−11.451, P<0.0001). ABCB1_rs1128503 (C/C vs T/T: OR=0.57, 95% CI=0.311−1.047, P=0.070) and ERCC1_rs11615 (A/A vs G/G: OR=1.75, 95% CI=0.901−3.397, P=0.098) were potential independent risk factors for C1D15 grade 3/4 neutropenia in non‐Asian patients. Palbociclib mPFS was consistent across genetic variants; exposure was not associated with ABCB1 genotype. Conclusion This is the first comprehensive assessment of pharmacogenetic data in relationship to exposure to a CDK4/6 inhibitor. Pharmacogenetic testing may inform about potentially increased likelihood of patients developing severe neutropenia (NCT01740427, NCT01942135). Implications for Practice Palbociclib plus endocrine therapy improves HR+/HER2– advanced breast cancer (ABC) outcomes, but is commonly associated with neutropenia. Genetic variants in ABCB1 may influence palbociclib exposure, and in ERCC1 are associated with chemotherapy‐induced severe neutropenia. Here, the associations of single nucleotide polymorphisms in these genes and baseline characteristics with neutropenia were assessed. Low baseline absolute neutrophil count was a strong risk factor (P<0.0001) for grade 3/4 neutropenia. There was a trend indicating that ABCB1_rs1128503 and ERCC1_rs11615 were potential risk factors (P<0.10) for grade 3/4 neutropenia in non‐Asian patients. Pharmacogenetic testing could inform clinicians about the likelihood of severe neutropenia with palbociclib.
, Irene Brana, Daruka Mahadevan, Taofeek Owonikoko, Emiliano Calvo, Danny Rischin, Victor Moreno, Kyriakos P. Papadopoulos, Marka Crittenden, Silvia Formenti, et al.
Published: 4 May 2021
by Wiley
The Oncologist; doi:10.1002/onco.13810

Abstract:
Lessons Learned Cemiplimab in combination with radiation therapy, cyclophosphamide, and granulocyte macrophage colony‐stimulating factor (GM‐CSF) did not demonstrate efficacy above what can be achieved with other PD‐1 inhibitor monotherapies in patients with Refractory and metastatic head and neck squamous cell carcinoma. The safety profile of cemiplimab combination therapy was consistent with previously reported safety profiles of cemiplimab monotherapy. No new safety signal was observed. Background Refractory and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) generally does not respond to PD‐1 inhibitor monotherapy. Cemiplimab is a human anti‐PD‐1 monoclonal antibody. An expansion cohort enrolled patients with R/M HNSCC in a phase I study combining cemiplimab plus radiation therapy (RT), cyclophosphamide, and granulocyte macrophage colony‐stimulating factor (GM‐CSF). Methods Patients with R/M HNSCC refractory to at least first‐line therapy and for whom palliative RT is clinically indicated received cemiplimab plus RT, cyclophosphamide, and GM‐CSF. The co‐primary objectives were the safety, tolerability, and efficacy of cemiplimab plus RT, cyclophosphamide and GM‐CSF in 15 patients (pts) with R/M HNSCC. Results Fifteen patients were enrolled. Patients discontinued treatment due to progression of disease. The most common treatment‐emergent adverse events (TEAEs) of any grade (Gr) were fatigue (40.0%), constipation (26.7%), and asthenia, dyspnea, maculo‐papular rash, and pneumonia (each 20%). The only Gr ≥3 TEAE that occurred in 2 pts was pneumonia (13.3%). By investigator‐assessment, there was 1 partial response (6.7%); disease control rate was 40.0% (95% CI: 16.3–67.7; 5 with stable disease); 7 patients had progressive disease and 2 were not evaluable. Median progression‐free survival by investigator‐assessment was 1.8 months (95% CI: 1.7–4.7). Conclusion The regimen demonstrated tolerability but not efficacy above that which can be achieved with anti‐PD‐1 inhibitor monotherapy for R/M HNSCC.
Ana‐Alicia Beltran‐Bless, Brent Vandermeer, Alexander Paterson, Ian Gunstone, Leonard Kaizer, Angel Arnaout, Lisa Vandermeer,
Published: 4 May 2021
by Wiley
The Oncologist; doi:10.1002/onco.13808

Abstract:
While accepting that oncologists should plan for a future beyond full‐time oncology, there is little practical guidance for a successful transition into retirement. Previously, we provided strategies for various aspects of retirement planning. However, this became significantly more complicated as we face newer issues such as; the COVID‐19 pandemic, the move to virtual patient care, greater awareness of burnout, as well as the increasing burden of regulatory issues such as the electronic medical record (EMR). It is evident that more prospective information is needed to guide oncologists in planning their retirement.
Leyre Zubiri, Rachel P. Rosovsky, Meghan J. Mooradian, Aj Piper‐Vallillo, Justin F. Gainor, Ryan J. Sullivan, Daniel Marte, Genevieve M. Boland, Xin Gao, Ephraim P. Hochberg, et al.
Published: 1 May 2021
by Wiley
The Oncologist; doi:10.1002/onco.13807

Abstract:
Background The Coronavirus Disease‐2019 (COVID‐19) pandemic has significantly impacted healthcare systems. However, to date, the trend of hospitalizations in the oncology patient population has not been studied and the frequency of nosocomial spread to cancer patients is not well‐understood. The objectives of this study were to evaluate the impact of COVID‐19 on inpatient oncology census and determine the nosocomial rate of COVID‐19 in cancer patients admitted at a large academic center. Materials and methods Medical records of cancer patients diagnosed with COVID‐19 and admitted were reviewed to evaluate the temporal trends in inpatient oncology census during pre‐COVID (Jan 2019‐Feb 2020), COVID (March‐May 2020), and post‐COVID surge (June‐August 2020) in the region. In addition, nosocomial infection rates of SARS‐CoV‐2 were reviewed. Results Overall, the daily inpatient census was steady in 2019 (median=103; range:92‐118) and until February 2020 (median=112; range:102‐114). However, there was a major decline from March to May 2020 (median=68; range:57‐104), with 45.4% lower admissions during April 2020. As the COVID surge eased, the daily inpatient census over time returned to the pre‐COVID baseline (median=103; range:99‐111). One patient (1/231, 0.004%) had SARS‐CoV‐2 positive test 13 days after hospitalization and it is unclear if it was nosocomial or community spread. Conclusion In this study, inpatient oncology admissions decreased substantially during the COVID surge, but over time returned to the pre‐COVID baseline. With aggressive infection control measures, the rates of nosocomial transmission were exceedingly low and should provide reassurance to those seeking medical care, including inpatient admissions when medically necessary. Implications for Practice The COVID‐19 pandemic has had a major impact on the healthcare system, and cancer patients are a vulnerable population. As a result of the urgent need for inpatient capacity, non‐COVID care has been deferred or delayed. In our study, we observe a drastic decline in the daily inpatient oncology census from March to May 2020 compared to the same time frame in the previous year. We investigate reasons for this decline. The concern is that some patients and providers may be deferring admission because of fear of the individual acquiring COVID in the hospital. However, we analyzed the nosocomial rate of COVID infection in admitted cancer patients to our center confirming that none of the patients in this study acquired the infection while hospitalized. These findings suggest that aggressive infection control measures can help mitigate the nosocomial infection risk among cancer patients and that the inpatient setting is a safe environment, providing reassurance to those seeking medical care.
Hitoshi Kanno, Hironori Nagata, Akihiro Ishiguro, Satoshi Tsuzuranuki, Shintaro Nakano, Takahiro Nonaka, Koushin Kiyohara, Toshinari Kimura, Akihiko Sugawara, Yuzuru Okazaki, et al.
Published: 29 April 2021
by Wiley
The Oncologist; doi:10.1002/onco.13805

Abstract:
The Ministry of Health, Labour and Welfare approved a drug called Borofalan (10B), a treatment system, and a dose calculation program for boron neutron capture therapy (BNCT) in March 2020. The application pertaining to the products submitted to the Pharmaceuticals and Medical Devices Agency was supported by a Japanese open‐label uncontrolled trial (Study 002) in patients with unresectable locally recurrent head and neck squamous cell carcinoma after chemoradiotherapy or radiotherapy, or in those with unresectable locally advanced or locally recurrent (LA/LR) head and neck non‐squamous cell carcinoma. The drug was administered as a single intravenous dose using infusion rates of 200 mg/kg/h for the first two hours after the start of administration and 100 mg/kg/h during irradiation. Neutrons irradiation was performed using the devices at a single dose of 12 Gy‐Eq. for oral, pharyngeal, or laryngeal mucosa for up to 60 minutes from two hours after the start of drug administration. The primary endpoint was the overall response rate (ORR). The results of Study 002 showed that the ORR [90% confidence interval (CI)] (%) based on an assessment of the Independent Central Review Committee per Response Evaluation Criteria in Solid Tumors (RECIST) ver.1.1 was 71.4 [51.3, 86.8]. The lower limit of the 90% CI exceeded the pre‐specified threshold for ORR. When BNCT is applied to patients with unresectable LA/LR head and neck cancer, precautions should be taken, and patients should be monitored for possible onset of dysphagia, brain abscess, skin disorder, crystal urine, cataract, and/or carotid hemorrhage. Implications for Practice Borofalan (10B), a treatment system, and a dose calculation program for boron neutron capture therapy (BNCT) have demonstrated significant efficacy based on the result of an open‐label uncontrolled trial (Study 002) in which the overall response rate was determined as the primary endpoint for patients with unresectable locally advanced or locally recurrent head and neck cancer. Although no information about survival benefits has been obtained, the BNCT will become an effective treatment option that is expected to manage local lesions that are intractable with any standard therapy. In addition, the BNCT is expected to maintain the quality of life of the intended patient population, on account of its high tumor selectivity and low invasiveness.
Stuart Turner, Stephen Chia, Hemanth Kanakamedala, Wei‐Chun Hsu, Jinhee Park, David Chandiwana, Antonia Ridolfi, Chu‐Ling Yu, Juan Pablo Zarate,
Published: 28 April 2021
by Wiley
The Oncologist; doi:10.1002/onco.13804

Abstract:
Background The BYLieve trial (NCT03056755) confirmed efficacy and safety of alpelisib with fulvestrant for hormone receptor‐positive (HR+), human epidermal growth factor receptor‐2–negative (HER2−), PIK3CA‐mutated advanced breast cancer (ABC), after cyclin‐dependent kinase 4/6 inhibitor (CDK4/6i) with an aromatase inhibitor (AI) as immediate prior therapy. Further analyses were performed to compare efficacy from BYLieve with effectiveness of standard treatment in the real‐world setting. Patients and Methods Patients who progressed on a CDK4/6i plus AI and were treated with alpelisib with fulvestrant in BYLieve were matched with a real‐world patient cohort who received standard of care from a de‐identified clinico‐genomics database (CGDB). Primary and secondary endpoints were to compare progression‐free survival (PFS), estimated by the Kaplan‐Meier method, and the proportion of patients remaining progression‐free at 6 months, respectively, between the 2 cohorts. Results A total of 855 patients with PIK3CA‐mutant disease who had prior CDK4/6i plus hormone therapy were selected from the CGDB; further matching to 120 patients from BYLieve selected 95 patients without exposure to HER2‐targeting agents, clinical study drug, or alpelisib. In unadjusted and post‐matching results, primary and secondary endpoints favored treatment with alpelisib with fulvestrant in BYLieve over standard treatments in the real‐world cohort. Post‐adjustment, median PFS for patients treated with alpelisib in BYLieve was 7.3 versus 3.7 months in the real‐world cohort, and 6‐month PFS was 54.6% versus 40.1%, respectively. Conclusion Matched/weighted analysis comparing BYLieve with the real‐world setting further supports the clinical benefit of alpelisib with fulvestrant for treatment of HR+, HER2−, PIK3CA‐mutant ABC post‐CDK4/6i treatment. Implications for Practice Approximately 40% of patients with hormone receptor‐positive (HR+), human epidermal growth factor receptor‐2–negative (HER2−) advanced breast cancer (ABC) have PIK3CA‐mutated tumors, which have been associated with endocrine therapy resistance. Alpelisib, an α‐selective phosphatidylinositol‐3‐kinase (PI3Kα) inhibitor, demonstrated significantly improved progression‐free survival in SOLAR‐1 and demonstrated clinical efficacy in BYLieve when combined with fulvestrant. Data are limited in comparing the efficacy of alpelisib combined with fulvestrant with effectiveness of standard therapy post‐CDK4/6i treatment. Using real‐world data, this is the first analysis comparing alpelisib combined with fulvestrant with standard treatments for HR+, HER2−, PIK3CA‐mutant ABC in the post‐CDK4/6i setting.
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