Lower Eastern Cooperative Oncology Group Research Articles

Single-fraction radiation retreatment for bone metastases: role of a rapid access clinic

ObjectivesThis study investigates retreatment rates in single-fraction radiation therapy (SFRT) for painful bone metastasis in patients with limited life expectancy. We compared retreatment-free survival (RFS) in patients from a rapid...

Expression of CD30 in Patients with Diffuse Large B-Cell Lymphoma and Clinical Significance

To investigate the expression and clinical significance of CD30 in patients with diffuse large B-cell lymphoma (DLBCL). A retrospective analysis was conducted on 124 cases of primary DLBCL diagnosed at Changzhou Second People's Hospital Affiliated with Nanjing Medical University from January 2018 to July 2020. The expression of CD30 in patients with DLBCL was detected by immunohistochemical method, and the clinicopathological characteristics were analyzed and compared between CD30+ and CD30- groups. Kaplan-Meier analysis was used for survival analysis. The relationship between CD30 expression and clinical features and prognosis were analyzed. Among the 124 patients with DLBCL, 19 patients expressed CD30, and the positive rate is 15.32%. The clinico-pathological characteristics of CD30+ in patients with DLBCL were characterized by low age, more common in males, fewer extranodal lesions, lower international prognostic index (IPI), GCB type being more common in Hans subtype, and achieving better therapeutic effects (P < 0.05). However, there were no significant statistical differences in B-symptoms (P =0.323), Ann Arbor staging (P =0.197), Eastern Cooperative Oncology Group (ECOG) score (P =0.479), lactate dehydrogenase (LDH) (P =0.477), and the involvement of bone marrow (P =0.222). There were significant differences in OS and PFS between the CD30+ and CD30- groups (χ2=5.653, P =0.017; χ2＝4.109，P =0.043), the CD30+ group had a better prognosis than that of the CD30- group. The results of subgroup analysis showed that the CD30+ group in the IPI score=1-2, LDH elevated group had a better prognosis (P < 0.05). In the subgroups of Ann Arbor staging III-IV (P =0.055) and non GCB type (P =0.053), the CD30+ group had a good prognosis trend, but the difference was not statistically significant. The results of univariate analysis showed that the good prognosis of DLBCL patients was closely related to CD30+ expression, no B-symptoms, early Ann Arbor staging, low ECOG score, normal LDH, low IPI score, fewer extranodal involvement, and obtaining the best therapeutic effect as CR (all P <0.05). COX multivariate regression analysis showed that the presence of B-symptoms and achieving the best therapeutic effect as Non-CR were independent risk factors affecting the prognosis of DLBCL patients (P < 0.05). The CD30+ expression in DLBCL patients indicates a good prognosis and has certain diagnostic value in evaluating the prognosis of DLBCL patients.

O105: Evaluating Surgical Approaches in Non-Small Cell Lung Cancer: Lobectomy vs Sublobar Resection

Abstract Background Lung Cancer remains the leading cause of cancer-related mortality, with non-small cell lung cancer (NSCLC) accounting for 85% of cases. Lobectomy has long been regarded as the gold-standard treatment for early-stage NSCLC. A shifting paradigm towards lung-sparing procedures such as sublobar resection, may benefit patients with limited respiratory reserve or high comorbidity index. This study aims to compare survival outcomes between patients undergoing lobectomy and sublobar resection. Methods This was a tertiary retrospective cohort study comparing disease-free survival (DFS), overall survival (OS) and postoperative outcomes in lobectomy and sublobar patients between 2013 and 2023 (n=3983). Propensity matched analysis was employed to adjust for treatment selection bias, calculated using a logistic regression model and incorporated eight covariates (n=528). Baseline, post-operative, and survival data were extracted from the hospital database. Comparison of baseline and post-operative characteristics involved Wilcoxon rank sum test, Fisher’s exact test and Pearson’s Chi-squared test. Kaplan Meier estimates and Multivariate Cox Regression were used to evaluate survival. p&amp;lt;0.05 was considered significant. Results No significant inter-cohort differences were observed in either DFS (log-rank p=0.32), OS (log-rank p=0.47), or 90-day mortality (log-rank p=0.78). Sublobar resection exhibited shorter post-operative length of stay (p&amp;lt;0.05). Conversely, both approaches demonstrated comparable resection margins and complication rates. Significant predictors of survival were age, gender and low Eastern Cooperative Oncology Group (ECOG) performance status (p&amp;lt;0.05). Conclusion These findings further support the non-inferiority of sublobar resection to lobectomy for stage 1 lung cancer. Additionally, improved perioperative outcomes may make sublobar resection more desirable for higher risk patients.

Disparities and trends in biomarker testing in metastatic colorectal cancer.

29 Background: Several therapies with biomarker-based indications have received approvals for use in metastatic colorectal cancer (mCRC) in the past decade. Consequently, biomarker testing is integral for treatment decisions, and guidelines recommend universal RAS, BRAF, and microsatellite instability (MSI)/ mismatch repair protein (MMR) testing in patients with mCRC. This study describes the frequency of biomarker testing in mCRC and explores variables influencing testing patterns. Methods: This study used the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database, which contains patient-level data originating from approximately 280 cancer clinics in the United States (~800 sites of care).Adult patients diagnosed with mCRC after January 1, 2013 who received at least 1 line of treatment were included. The percentage of patients who received KRAS, NRAS, BRAF, and MSI/MMR testing as reported in the database was determined. Univariate and multivariable analyses were performed to evaluate factors associated with completion of biomarker testing. Results: A total of 25,937 patients were included in this analysis. Among these, 81.6%, 60.5%, 63.7%, and 73.4% had documented test results for KRAS, NRAS, BRAF, and MSI/MMR, respectively, and 51.6% received completed testing for all 4 biomarkers. In a multivariable analysis including 13,894 patients with complete data available for assessed variables, younger age at diagnosis, non-Hispanic or Latino ethnicity, white versus black race, more recent year of diagnosis, community versus academic practice setting, higher socioeconomic status index, and lower Eastern Cooperative Oncology Group performance status (ECOG PS) were associated with increased completion of biomarker testing. Year of diagnosis and ECOG PS had the largest impact. Frequency of testing completion was 73.7% in those diagnosed in or after 2020 compared to 21.5% in those diagnosed from 2013-2015 (odds ratio [OR] 8.56, p&lt;0.001). Complete testing was performed in 59.3% of those with an ECOS PS of 0, compared to 55.1% (OR 0.86, p&lt;0.001), 45.7% (OR 0.62, p&lt;0.001), 38.0% (OR 0.43, p&lt;0.001), and 16.7% (OR 0.16, p=0.019) of those with an ECOG PS of 1, 2, 3, and 4, respectively. Notably, testing was completed in 47.2% versus 50.5% of patients with Hispanic or Latino ethnicity versus non-Hispanic or Latino ethnicity (OR 0.69; p&lt;0.001), and in 48.8% versus 51.6% of black versus white patients (OR 0.82, p=0.001). Conclusions: Based on results from the Flatiron Health database, rates of guideline-recommended biomarker testing in mCRC remain suboptimal and are impacted by age, ethnicity, race, socioeconomic status, practice setting, ECOG PS, and year of diagnosis. These results highlight important disparities in testing that require attention. Encouragingly, rates of testing have significantly increased over the past decade as new biomarker-directed therapies have become available.

Primary site surgery of de novo stage IV HER2-positive breast cancer in the era of new drug treatments.

The surgical treatment of the primary site has been a subject of controversy in patients with de novo metastatic breast cancer. In recent years, studies using large databases and retrospective analyses have provided evidence of the survival benefits of localized surgery for these patients. However, due to the improved prognosis associated with novel antitumor agents and the widespread use of anti-HER2 therapy, it is important to investigate the role of primary site surgery in the context of new drug treatments for stage IV HER2-positive breast cancer. This retrospective analysis included patients with metastatic breast cancer at diagnosis who were consulted at the First Hospital of Jilin University between 2016 and 2022. We compared the patients' clinical and pathological characteristics, treatment regimens, and prognosis between the surgery and non-surgery groups. A total of 96 patients with stage IV HER2-positive breast cancer were included in the study, with 24 patients (25%) undergoing surgery for the primary lesion. Patients with lower Eastern Cooperative Oncology Group (ECOG) scores, earlier T-stage, metastases confined to one organ/site, and fewer metastases were more likely to undergo surgery. Patients in the surgical group had longer progression-free survival (median 25.7 vs. 15.9 months, p=0.073) and overall survival (median 79.1 vs. 48 months, p=0.073) compared to patients in the non-surgical group, however, there was no statistical difference. Univariate and multivariate Cox regression analysis suggested that the choice of first-line targeted therapy regimens rather than surgical treatment influenced the patients' prognoses. In the subgroup of patients receiving first-line targeted therapy with trastuzumab plus pertuzumab, the decision to undergo surgery on the primary site did not have a statistically significant effect on prognosis. Primary site surgery does not improve the prognosis of de novo stage IV HER2-positive breast cancer. In the era of anti-HER2 therapy, primary surgery is not recommended, except in exceptional circumstances.

Efficacy and safety of sintilimab combined with apatinib as third-line or above therapy for patients with advanced or metastatic gastric cancer.

This study aimed to evaluate the efficacy and safety of the combination of sintilimab and apatinib for the treatment of patients with advanced or metastatic gastric cancer (GC) and gastroesophageal junction (GEJ) cancer. This retrospective study analyzed data from 34 patients who had advanced or metastatic GC/GEJ cancer and received the combination therapy of sintilimab and apatinib as a third-line or above treatment. The primary endpoint was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. Among the 34 patients, none achieved a complete response (CR), 3 patients (8.8%) achieved a partial response, 23 patients (67.6%) had stable disease, and 8 patients (23.5%) experienced progressive disease. The ORR and DCR were 8.8% and 76.5%, respectively. The median PFS was 6.0 months (95% CI: 3.6-8.4), and the median OS was 11.6 months (95% CI: 8.1-15.1). Subgroup analysis revealed significant differences in OS between patients with high and low Eastern Cooperative Oncology Group Performance Status scores and between patients with and without a history of gastrectomy. Common adverse events (AEs) during treatment included fatigue (52.9%), anemia (47.1%), leukopenia (26.5%), hypothyroidism (23.5%), nausea and vomiting (20.6%), neutropenia (20.6%), and thrombocytopenia (17.6%), most of which were grade 1 and 2 AEs. No deaths occurred due to AEs. These findings indicate that the combination of sintilimab and apatinib has a favorable therapeutic effect in patients with advanced GC. Moreover, the AEs associated with this therapy are generally manageable.

Clinical factors associated with autologous stem cell transplantation outcomes in multiple myeloma: upfront transplant with MEL200 remains the standard of care.

Autologous stem cell transplantation (ASCT) remains the mainstay of the treatment in newly diagnosed transplant-eligible multiple myeloma (MM) patients. This retrospective study was performed to investigate the potential prognostic markers which may modify transplant course in a total of 256 ASCT recipients [median age: 58 (30-74) years; male/female: 138/118], including pretransplant (PET0) and day + 60 (PET2) PET/CT assessments and comparative analysis of melphalan (Mel) dose. Better responses with significantly higher complete response/very good partial response rates were achieved in patients who proceeded to transplant within 301days from diagnosis (p < 0.001). Patients who had received < 1.5 lines of treatment prior to transplant had significantly higher probability of overall survival (OS) (p = 0.004) and progression-free survival (PFS) (p < 0.001). The probability of OS was significantly higher in patients with low Eastern Cooperative Oncology Group (ECOG) performance score (PS = 0-1) (p = 0.003) and HCT-Comorbidity Index (HCT-CI = 0) (p = 0.011). The number of involved areas (p = 0.028) and maximum standardized uptake value (SUVmax) (p = 0.021) in PET0 represented significant impact on OS. The probabilities of OS (p < 0.001) and PFS (p = 0.01) were significantly better with Mel200 mg/m2 conditioning compared to Mel140 mg/m2. Conditioning with Mel200 mg/m2, early and upfront ASCT and low pretransplant treatment burden were found to be significantly associated with ASCT outcome in MM patients. Despite its predictor impact on survival and prognosis, further studies are warranted to standardize PET/CT-based response assessments before being used as a guide for treatment decisions in clinical practice.

Deep learning–based assessment of CT markers of sarcopenia and myosteatosis for outcome assessment in patients with advanced pancreatic cancer after high-intensity focused ultrasound treatment

ObjectivesTo evaluate the prognostic value of CT-based markers of sarcopenia and myosteatosis in comparison to the Eastern Cooperative Oncology Group (ECOG) score for survival of patients with advanced pancreatic cancer treated with high-intensity focused ultrasound (HIFU).Materials and methodsFor 142 retrospective patients, the skeletal muscle index (SMI), skeletal muscle radiodensity (SMRD), fatty muscle fraction (FMF), and intermuscular fat fraction (IMFF) were determined on superior mesenteric artery level in pre-interventional CT. Each marker was tested for associations with sex, age, body mass index (BMI), and ECOG. The prognostic value of the markers was examined in Kaplan-Meier analyses with the log-rank test and in uni- and multivariable Cox proportional hazards (CPH) models.ResultsThe following significant associations were observed: Male patients had higher BMI and SMI. Patients with lower ECOG had lower BMI and SMI. Patients with BMI lower than 21.8 kg/m2 (median) also showed lower SMI and IMFF. Patients younger than 63.3 years (median) were found to have higher SMRD, lower FMF, and lower IMFF. In the Kaplan-Meier analysis, significantly lower survival times were observed in patients with higher ECOG or lower SMI. Increased patient risk was observed for higher ECOG, lower BMI, and lower SMI in univariable CPH analyses for 1-, 2-, and 3-year survival. Multivariable CPH analysis for 1-year survival revealed increased patient risk for higher ECOG, lower SMI, lower IMFF, and higher FMF. In multivariable analysis for 2- and 3-year survival, only ECOG and FMF remained significant.ConclusionCT-based markers of sarcopenia and myosteatosis show a prognostic value for assessment of survival in advanced pancreatic cancer patients undergoing HIFU therapy.Clinical relevance statementThe results indicate a greater role of myosteatosis for additional risk assessment beyond clinical scores, as only FMF was associated with long-term survival in multivariable CPH analyses along ECOG and also showed independence to ECOG in group analysis.Key Points• This study investigates the prognostic value of CT-based markers of sarcopenia and myosteatosis for patients with pancreatic cancer treated with high-intensity focused ultrasound.• Markers for sarcopenia and myosteatosis showed a prognostic value besides clinical assessment of the physical status by the Eastern Cooperative Oncology Group score. In contrast to muscle size measurements, the myosteatosis marker fatty muscle fraction demonstrated independence to the clinical score.• The results indicate that myosteatosis might play a greater role for additional patient risk assessments beyond clinical assessments of physical status.

Treatment-Free Survival After Nivolumab vs Pembrolizumab vs Nivolumab-Ipilimumab for Advanced Melanoma

Treatment-free survival (TFS) represents an alternative time-to-event end point, accurately characterizing time spent free of systemic therapy, providing a more patient-centric view of immune checkpoint inhibitor (ICI) therapy regimens. There remains a lack of studies evaluating TFS outcomes among patients with advanced melanoma who are receiving immunotherapy, especially outside of the clinical trial setting. To evaluate TFS outcomes for patients with advanced melanoma receiving first-line ICI therapy outside of a clinical trial setting. This multicenter cohort study of patients with advanced melanoma receiving first-line ICI therapy between August 1, 2013, and May 31, 2020, was conducted in Alberta, Canada. Data analysis was performed in August 2022. Patients received standard-of-care, first-line ICI therapy treatment regimens including single-agent nivolumab, single-agent pembrolizumab, or ipilimumab-nivolumab. Treatment-free survival was defined as the difference in the 36-month restricted mean survival time between 2 conventional survival end points: (1) time from treatment initiation to ICI cessation, death, or censoring at last follow-up and (2) time from treatment initiation to subsequent systemic anticancer therapy, death, or censoring at last follow-up. A total of 316 patients with advanced melanoma receiving first-line nivolumab (n = 51; median age, 66 years [IQR, 56-78 years]; 31 men [60.8%]), pembrolizumab (n = 158; median age, 69 years [IQR, 60-78 years]; 112 men [70.9%]), or combination nivolumab-ipilimumab (n = 107; median age, 53 years [IQR, 42-60 years]; 72 men [67.3%]) were included. Treatment groups were similar with regard to sex, primary tumor location, and presence of metastasis, although patients receiving combination nivolumab-ipilimumab had a lower Eastern Cooperative Oncology Group status, were younger, and were more likely to be BRAF V600E positive than those receiving anti-programmed cell death protein 1 (anti-PD-1) monotherapy. The restricted mean TFS was longer for nivolumab-ipilimumab (12.4 months [95% CI, 8.8-16.0 months]) compared with nivolumab (8.9 months [95% CI, 4.4-13.5 months]) and pembrolizumab (11.1 months [95% CI, 8.5-13.8 months]). During the 36-month follow-up interval, patients treated with nivolumab-ipilimumab spent 34.4% of their time (12.4 of 36 months) not receiving systemic anticancer treatments compared with 30.8% (11.1 of 36 months) and 24.7% (8.9 of 36 months) of the time for the pembrolizumab and nivolumab treatment groups, respectively. This cohort study of patients with advanced melanoma receiving first-line ICI therapy suggests that TFS represents a patient-centric, informative end point. Patients treated with combination nivolumab-ipilimumab spent more time alive and free from systemic anticancer therapy than those treated with anti-PD-1 monotherapy alone.

Assessing Oncologists' Adoption of Biomarker Testing in Metastatic Colorectal Cancer Using Real-World Data.

Despite national guideline recommendations for universal biomarker testing (KRAS, NRAS, BRAF, and mismatch repair and microsatellite instability [MMR/MSI]) in all patients with metastatic colorectal cancer (mCRC), little is known regarding adherence to these recommendations in routine practice. We retrospectively reviewed patients with mCRC diagnosed between January 1, 2013, and December 27, 2018, from a de-identified electronic health record-derived database. We analyzed disparities in KRAS, NRAS, BRAF, and MMR/MSI testing by race, age, sex, and insurance status using χ2 tests and t tests. We evaluated changes in biomarker testing over time with attention to changes around dates of landmark publications and guideline updates using χ2 tests and Cochran-Armitage tests. A total of 20 333 patients were identified of which 66.6% had test results for any biomarker. Rates of test results for all 4 biomarkers statistically significantly increased over time (P < .001). However, as of June 30, 2018, the rate of test results was only 46% for NRAS, 56% for KRAS, and 46% for BRAF. As of December 31, 2017, the rate of MMR/MSI testing was 59%. Higher documented testing rates were associated with younger age, lower Eastern Cooperative Oncology Group performance status, and commercial insurance. There were no clinically meaningful and/or statistically significant differences in documented testing rates by tumor sidedness, race, sex, or initial stage. Increased rates of documented testing for NRAS, BRAF, and MMR/MSI in mCRC was seen between 2013 and 2018 reflecting adoption of guideline recommendations. However, the rate of documented testing remains lower than expected and warrants additional research to understand the extent to which this may represent a clinical practice quality concern.

Ixazomib combined with lenalidomide and dexamethasone chemotherapy for newly diagnosed multiple myeloma in China-Compared with bortezomib/lenalidomide/dexamethasone.

To compare the response and safety of Ixazomib/Lenalidomide/Dexamethasone (IRd) and Bortezomib/Lenalidomide/Dexamethasone (VRd) treatment in newly diagnosed multiple myeloma (MM). This was a single-center retrospective analysis in Xiangtan Central Hospital. A total of 52 newly diagnosed MM patients from June 2019 to June 2021 were enrolled and divided into the IRd (n=21) and VRd (n=31) groups. After 4cycles of chemotherapy, the best response and adverse events were recorded. Moreover, the progression-free survival (PFS) and overall survival (OS) were calculated. Patients in IRd group and VRd group showed similar PFS (Log-rank p=0.70), OS (Log-rank p=0.61) and overall response rate (83.87% vs 90.48%, p=0.803). In addition, patients in VRd group showed lower Eastern Cooperative Oncology Group scores (p=0.047), and higher incidence of peripheral sensory neuropathy (0.00% vs 19.35%, p=0.032) than that of patients in IRd group. Compared to VRd regimen, IRd had the similar efficacy, better safety, and may be more convenient for patients with poor basic condition for newly diagnosed MM. This study provides an insight for physicians to use IRd as first-line treatment in MM.

The Application of Nimotuzumab Combined With Definitive Chemoradiotherapy Toward the Treatment of Locally Advanced Cervical Esophageal Carcinoma: A Retrospective Study.

ObjectiveTo evaluate the safety and effectiveness of nimotuzumab in combination with chemoradiotherapy for locally advanced cervical esophageal squamous cell carcinoma.MethodsRetrospective analysis was conducted from September 2012 to February 2017 among 50 locoregional-advanced cervical esophageal carcinoma (CEC) patients who received concurrent chemoradiotherapy (CRT) combined with or without nimotuzumab at Ningbo Medical Center Lihuili Hospital. Intensity-modulated radiotherapy (IMRT) was administrated on all patients. All patients were divided into two groups, of which 26 (Group A) received 200 mg (22 of 50) or 400 mg (4 of 50) of nimotuzumab per week with CRT and 24 (Group B) received definitive CRT.ResultsThe median follow-up time was 23 months. The median overall survival (OS) and progression-free survival (PFS) were 40.6 and 21.1 months for all, respectively. The 1-, 2-, and 3-year OS rates on the whole were 79.6%, 62.1%, and 47.8%. There was no statistical difference in overall response rate and disease control rate between the two groups. Patients treated with nimotuzumab (group A) had better PFS than the definitive CRT group (group B) (P < 0.05). However, the median OS was 41.4 months in group A and 32.4 months in group B, respectively (P = 0.517). Multivariate analysis showed that PFS among those with lower Eastern Cooperative Oncology Group (ECOG) score (HR = 5.11; P < 0.01), stage II (HR = 9.52; P < 0.01) and the application of nimotuzumab combined with CRT (HR = 0.16; P < 0.01) was much longer. Furthermore, ECOG, stage, C-reactive protein (CRP) baseline, and histological grade can also be used as independent predictors of OS. Grade >3 adverse reactions were not observed. The most common adverse event related to nimotuzumab was mild fever and the occurrence rate was 19% (5 of 26). The incidence of anemia was 65.4% in group A and 87.5% in group B (P < 0.05).ConclusionsFor locoregional-advanced CEC, nimotuzumab combined with IMRT and concomitant chemotherapy was tolerated and effective. In addition, patients with a normal pretherapeutic serum CRP level (CRP < 10 mg/L) can achieve better OS.

Preventive Effect of Hippocampal Sparing on Cognitive Dysfunction of Patients Undergoing Whole-Brain Radiotherapy and Imaging Assessment of Hippocampal Volume Changes

Objective Preventive effect of hippocampal sparing on cognitive dysfunction of patients undergoing whole-brain radiotherapy and imaging assessment of hippocampal volume changes. Methods Forty patients with brain metastases who attended Liaoning Cancer Hospital from January 2018 to December 2019 were identified as research subjects and were randomly divided into a control group and an experimental group, with 20 cases in each group. The control group was treated with whole-brain radiotherapy (WBRT), and the experimental group was treated with hippocampal sparing-WBRT (HS-WBRT). The Montreal Cognitive Assessment (MoCA) score, Eastern Cooperative Oncology Group (ECOG) score, cancer quality-of-life questionnaire (QLQ-C3O) score, hippocampal volume changes, and prognosis of the two groups were compared. Results The MoCA scores decreased in both groups at 3, 6, and 12 months after radiotherapy, with significantly higher scores in the experimental group than in the control group (P < 0.05). After radiotherapy, both groups had lower ECOG scores, with those in the experimental group being significantly lower than those in the control group (P < 0.05). After radiotherapy, the QLQ-C30 score was elevated in both groups, and that of the experimental group was significantly higher than that of the control group (P < 0.05). The experimental group outperformed the control group in terms of the prognosis (P < 0.05). The hippocampal volume of the control group was significantly smaller than that of the experimental group (P < 0.05). Conclusion The application of hippocampal sparing in patients receiving whole-brain radiotherapy is effective in preventing cognitive dysfunction, improving the quality of life and prognosis of patients, and avoiding shrinkage of hippocampal volume.

Symptoms, performance status and quality of life in cancer patients receiving palliative care

Aim: The aim of the study was to describe the symptoms experienced by cancer patients receiving palliative care, patients’ performance and the effects on their quality of life. Materials and Methods: This is a descriptive study and was conducted with 106 patients admitted to palliative care unit at a university hospital in Izmir, located in the west of Turkey, between December 2019 and April 2020. For data collection, Patient Information Form, “Eastern Cooperative Oncology Group (ECOG) Performance Status Scale”, “Edmonton Symptom Assessment Scale (ESAS)” and “Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) Scale” were applied. For data analysis, descriptive statistics, Chi-square test, Kruskall Wallis Analysis and linear regression analysis were used. Results: Patients reported that the most common symptoms experienced were fatigue, sense of being unwell, anxiety, sadness (depression) and pain. According to the regression analysis, there was a statistically significant difference between the total quality of life scores of the patients and pain, fatigue and nausea from the patients' ESAS symptoms. The quality of life scores were significantly lower in the patients who were hospitalized, had an advanced disease stage, did not have metastases or did not know their metastases status and had a low performance status ECOG. There was a statistically significant difference between patients' ECOG performance status and quality of life. Conclusion: Patients have multiple symptoms and poor quality of life. Our findings support the importance of symptom assessment and management to improve quality of life.

Uptake of Adjuvant Durvalumab After Definitive Concurrent Chemoradiotherapy for Stage III Nonsmall-cell Lung Cancer.

The addition of adjuvant durvalumab improves overall survival in locally advanced nonsmall-cell lung cancer (NSCLC) patients treated with definitive chemoradiation, but the real-world uptake of adjuvant durvalumab is unknown. We identified patients with stage III NSCLC treated with definitive concurrent chemoradiation from January 2018 to October 2020 from a statewide radiation oncology quality consortium, representing a mix of community (n=22 centers) and academic (n=5) across the state of Michigan. Use of adjuvant durvalumab was ascertained at the time of routine 3-month or 6-month follow-up after completion of chemoradiation. Of 421 patients with stage III NSCLC who completed chemoradiation, 322 (76.5%) initiated adjuvant durvalumab. The percentage of patients initiating adjuvant durvalumab increased over time from 66% early in the study period to 92% at the end of the study period. There was substantial heterogeneity by treatment center, ranging from 53% to 90%. In multivariable logistic regression, independent predictors of durvalumab initiation included more recent month (odds ratio [OR]: 1.05 per month, 95% confidence interval [CI]: 1.02-1.08, P=0.003), lower Eastern Cooperative Oncology Group score (OR: 4.02 for ECOG 0 vs. 2+, 95% CI: 1.67-9.64, P=0.002), and a trend toward significance for female sex (OR: 1.66, 95% CI: 0.98-2.82, P=0.06). Adjuvant durvalumab for stage III NSCLC treated with definitive chemoradiation was rapidly and successfully incorporated into clinical care across a range of community and academic settings in the state of Michigan, with over 90% of potentially eligible patients starting durvalumab in more recent months.

Performance status as prognostic factor in phase III trials of first-line chemotherapy of unresectable or metastatic pancreatic cancer: A trial-level meta-analysis.

For patients with unresectable or metastatic pancreatic adenocarcinoma (mPDAC), there are no standardized prognostic and predictive factors beyond performance status (PS). A poor PS, as defined by Eastern Cooperative Oncology Group (ECOG) score of 2 or more, has been related with a detrimental effect of chemotherapy. Therefore, even more trials enrolled patients with good PS. The current analysis aims to evaluate the results of PS as a prognostic factor in phase III trials of patients with mPDAC receiving first-line chemotherapy. A literature search on two databases, from 2000 to 2019, and a further selection of clinical trials were performed by predefined criteria. Twelve phase III studies have been included in the analysis: the trials, enrolling 5619 patients, confirmed the worse prognosis of patients with higher ECOG PS scores (hazard ratio [HR] = 1.45; 95% confidence interval [CI], 1.21-1.74; p-value<0.001), and a similar trend was evident for patients with an ECOG PS 1versus 0 (HR = 1.61; 95% CI, 1.43-1.80; p-value<0.001) in six studies, enrolling 2799 patients. Heterogeneity of trials was high, with I2 =91%. Some possible moderators have been suggested, such as the number of drugs in the chemotherapy regimen and the male gender. In conclusion, a low ECOG PS score appears to be related with a longer survival even in trials that excluded patients with an ECOG PS 2 score, but the meta-analyses reported high heterogeneity and publication bias.

Association of MUC19 Mutation With Clinical Benefits of Anti-PD-1 Inhibitors in Non-small Cell Lung Cancer.

Although anti-PD-1 inhibitors exhibit impressive clinical results in non-small cell lung cancer (NSCLC) cases, a substantial percentage of patients do not respond to this treatment. Moreover, the current recommended biomarkers are not perfect. Therefore, it is essential to discover novel molecular determinants of responses to anti-PD-1 inhibitors. We performed Whole Exome Sequencing (WES) in a cohort of 33 Chinese NSCLC patients. Patients were classified into the durable clinical benefit (DCB) and no durable benefit (NDB) groups. Infiltrating CD8+ cells in the tumor microenvironment (TME) were investigated by immunohistochemistry. We also used public datasets to validate our results. In our cohort, good clinical responses to anti-PD-1 inhibitors were more pronounced in younger patients with lower Eastern Cooperative Oncology Group (ECOG) scores and only extra-pulmonary metastasis. More importantly, we identified a novel MUC19 mutation, which was significantly enriched in DCB patients (P = 0.015), and MUC19-mutated patients had a longer progression-free survival (PFS) (hazard ratio = 0.3, 95% CI 0.1–0.9; P = 0.026). Immunohistochemistry results indicated that the MUC19 mutation was associated with increased infiltration by CD8+ T cells in the TME (P = 0.0313). When combining MUC19 mutation with ECOG scores and intra-pulmonary metastasis status, patients with more positive predictors had longer PFS (P = 0.003). Furthermore, MUC19 mutation was involved in immune responses and associated with a longer PFS in the Memorial Sloan-Kettering Cancer Center (MSKCC) cohort. Collectively, we identified that MUC19 mutations were involved in immune responses, and NSCLC tumors harboring mutated MUC19 exhibited good responses to anti-PD-1 inhibitors.

Modified Glasgow Prognostic Score predicts survival among advanced non-small cell lung carcinoma patients treated with anti-PD1 agents.

Immune checkpoint inhibitors were approved for advanced nonsmall cell lung cancer (NSCLC) treatment. Despite improved survival, not all patients benefit from these agents. Here, the prognostic impact of pretreatment modified Glasgow Prognostic Score (mGPS) and neutrophil-to-lymphocyte ratio (NLR) was assessed. From 77 patients included, 83.2% received at least one prior systemic therapy. Immune-related adverse events (irAE) occurred in 20 patients. A lower mGPS was associated with higher median overall survival (OS), and a lower Eastern Cooperative Oncology Group (ECOG), irAE and fewer metastatic sites with better survival. A trend towards greater OS and progression-free survival (PFS) was stated among patients with NLR <5. mGPS 0 was associated with better survival; ≥3 metastatic sites with worse PFS and OS; ECOG >2 with worse OS and irAE with better survival. Pretreatment mGPS seems to be useful for predicting survival among advanced NSCLC patients treated with anti-programmed cell death 1 drugs, with ECOG performance status, irAE occurrence, and number of metastatic sites acting as survival predictors.

Cytotoxic and targeted systemic therapy in patients with advanced cutaneous squamous cell carcinoma in the head and neck.

The outcomes of patients treated with cytotoxic or targeted systemic therapy is not well defined for cutaneous squamous cell carcinoma of the head and neck (cSCCHN). Patients with cSCCHN treated with cytotoxic or targeted systemic therapy were included. Patients were divided into two groups based on the presence of distant metastasis (M1 vs. M0) at presentation. A proportional hazards model was used to assess for independent predictors of overall survival. Of 129 patients with cSCCHN, 20 (16%) were M1 and 109 (84%) were M0. Independent predictors of improved survival were M0 status, treatment of locally advanced disease with radiotherapy, and lower Eastern Cooperative Oncology Group (ECOG) score. Survival was worse in M1 patients treated with cytotoxic or targeted systemic therapy and poor baseline performance status but improved in those receiving radiotherapy. These data can serve as historical controls for future systemic therapy trials, including immunotherapy.

An iodine-125 seed strand combined with a metal stent versus a metal stent alone for obstructive jaundice caused by pancreatic ductal adenocarcinoma

PurposeThe purpose of this study was to assess the efficacy of an iodine-125 (125I) seed strand combined with a metal stent compared with a metal stent for treatment of obstructive jaundice caused by pancreatic ductal adenocarcinoma (PDAC). Methods and MaterialsA retrospective analysis was carried out of patients who were referred to Shanghai Zhongshan Hospital of Fudan University with a diagnosis of PDAC between January 1, 2010 and January 31, 2019. A total of 110 consecutive patients with obstructive jaundice caused by PDAC were divided into the iodine-125 seed strand combined with a metal stent group (Group A = 48) and the metal stent group (Group B = 62). The primary outcome was stent obstruction–free survival time, and secondary outcomes were overall survival and complications. ResultsThe median stent obstruction–free survival time was 133.0 (95% confidence interval (CI): 166.093–149.907) days, and the median overall survival was 212.0 (95% CI: 187.183–236.817) days in all patients. Median stent obstruction–free survival time was 175 days (95% CI 103.165–246.835 days) in Group A versus 120 days (95% CI 87.475–152.525 days) in Group B (p = 0.035). A lower Eastern Cooperative Oncology Group (ECOG) score (p = 0. 000) and iodine-125 seed strand combined with metal stent implantation (p = 0.008) were associated with a longer stent obstruction–free survival time. Obstruction length (p = 0.083), ECOG score (p = 0.000), and iodine-125 seeds (p = 0.037) might have potential impact on stent obstruction–free survival time and were included for multivariable analysis using the Cox proportional hazards model. Stent restenosis was observed in 18.8% (9/48) of patients in Group A and 54.8% (34/62) in Group B, respectively. There was no significant difference in median survival between Group A and Group B (p = 0.409). The median survival in Group A was 209 days (95% CI 150.750–267.250) and 202 days (95% CI 190.624–233.376) in Group B. The median survival of patients with a lower ECOG score was better than that of patients with a higher ECOG score (267 days vs 132 days, p = 0.000). The Grade 3 or 4 complications occurred in 4 (8.3%) of the 48 patients in Group A (one case of hemobilia, one case of liver abscess, two cases of choleperitonitis) and in 5 (8.1%) of the 62 patients in Group B (one case of hemobilia, two cases of liver abscess, two cases of choleperitonitis) (p = 0.972). ConclusionsImplantation of an iodine-125 seed strand combined with a metal stent provides longer obstruction-free survival time compared with a metal stent in patients with obstructive jaundice caused by PDAC. It seems reasonable to choose an iodine-125 seed strand combined with a metal stent as a treatment for these patients.