Clinical Oncology Group Performance Status Research Articles

Comparing Preoperative Screening Tools for Elective Urologic Cancer Surgery: Insights from a Cluster Analysis

Introduction: The aim of this study was to evaluate the features and benefits of different geriatric screening tools for enhancing the perioperative care of patients who undergo elective cancer surgery using cluster analysis. Methods: This study was a retrospective, observational analysis of 1,019 consecutive patients who had elective major cancer surgery in the urology department of our hospital from October 2019 to January 2023. Before the surgery, a trained nurse screened the patients using six tools: Eastern Clinical Oncology Group performance status (ECOG-PS), flemish version of the triage risk screening tool (fTRST), geriatric-8 (G8), instrumental activities of daily living, patient health questionnaire-2 (PHQ-2), and simple questionnaire to rapidly diagnose sarcopenia (SARC-F). The study grouped the patients into four clusters based on their scores on these tools and compared their outcomes after the surgery. The outcomes included overall survival, ambulation failure, delirium, and severe complications. The study also examined how each screening tool was associated with the outcomes. Results: Based on their clinical data and screening results, we classified the patients into four groups: Healthy (73%), Depressive (11%), Intermediate (11%), and Unhealthy (5%). The Unhealthy group had the worst outcomes in overall survival (OS), ambulation failure, and delirium, followed by the Intermediate group. In addition, fTRST and SARC-F emerged as significant predictors of OS; ECOG-PS, fTRST, G8, and SARC-F of ambulation failure; ECOG-PS, fTRST, and G8 of delirium; and G8 of severe complications. Conclusion: Various geriatric screening tools were found to have the potential to forecast diverse postoperative outcomes.

Prognostic role of transcription factor ARID1A in patients with endometrial cancer of no specific molecular profile (NSMP) subtype

ObjectiveAs more than 50% of newly diagnosed endometrial cancers remain classified as ‘no specific molecular subtype’ (NSMP) due to a lack of established biomarkers to further improve molecular subtyping, this...

Comparative Effectiveness of Video and Face-to- Face Sessions to Educate Hospitalized Patients on Cancer Pain Management

Objective: Patients’ lack of knowledge of cancer pain management affects pain outcomes. This study compared the effectiveness of cancer pain management achieved in a previous retrospective study (“P-group”), in which hospitalized cancer pain individuals received no pain education, with the pain management achieved by 2 study groups. One group received pain management information via video sessions (“V-group”) and the other via face-to-face coaching (“F-group”). The study’s secondary aims were to compare the 2 interventions’ psychological, quality-of-life, and opioid-consumption impacts. Materials and Methods: This single-blinded, randomized, controlled trial enrolled hospitalized cancer pain patients aged between 18 and 70 with an Eastern Clinical Oncology Group performance status < 4. They were assigned to V- and F-groups to receive information on managing cancer pain. “Successful pain control” was defined as “no to mild pain” or a numerical rating scale score < 4 on Day 6. Pain intensity and opioid consumption (morphine-equivalent daily dosage) were recorded daily from baseline to Day 6. Psychological status (Hospital Anxiety and Depression Scale) and quality of life (Functional Assessment of Cancer Therapy–General) were assessed at baseline and Day 6. Results: Fifty-nine participants were analyzed (V-group: 31; F-group: 28). Both groups had significantly higher successful pain outcomes than the P-group (P < .001). The V- and F-groups had no significant differences in successful pain control (20 [65%] vs 19 [68%]; P = .787), psychological effects, quality of life, or opioid consumption. Conclusions: Video sessions are an alternative means of educating hospitalized cancer pain patients and reducing healthcare providers’ workloads.

422. ROBOT-ASSISTED MINIMALLY INVASIVE THORACO-LAPAROSCOPIC ESOPHAGECTOMY VERSUS MINIMALLY INVASIVE ESOPHAGECTOMY FOR RESECTABLE ESOPHAGEAL ADENOCARCINOMA, A RANDOMIZED CONTROLLED TRIAL (ROBOT-2-TRIAL)

Abstract For patients with esophageal adenocarcinoma or cancer of the gastroesophageal junction, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment with curative intent. Both conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison exists between MIE and RAMIE in the Western World for patients with esophageal adenocarcinoma. This is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group superiority trial. All adult patients (age ≥ 18 and ≤ 90 years) with histologically proven, surgically resectable (cT1-4a, N0–3, M0) esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 218) with resectable esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction are randomized to either RAMIE (n = 109) or MIE (n = 109). T. The primary outcome of this study is the total number of resected abdominal and mediastinal lymph nodes specified per lymph node station. Short-term results and the primary endpoint (total number of resected abdominal and mediastinal lymph nodes per lymph node station) will be analyzed and published after discharge of the last randomized patient within this trial. This is the first randomized controlled trial designed to compare RAMIE to MIE as surgical treatment for resectable esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction in the Western World. The hypothesis of the proposed study is that RAMIE will result in a higher abdominal and mediastinal lymph node yield specified per station compared to conventional MIE.

Efficacy and safety of chemoradiation therapy using one-shot cisplatin via hepatic arterial infusion for advanced hepatocellular carcinoma with major macrovascular invasion: a single-arm retrospective cohort study

BackgroundPatients with hepatocellular carcinoma (HCC) and macrovascular invasion (MVI) who receive systemic chemotherapy have a poor prognosis. This study aimed to determine if one-shot cisplatin (CDDP) chemotherapy via hepatic arterial infusion (HAI) combined with radiation therapy (RT) prior to systemic chemotherapy could improve the outcomes of these patients.MethodsThis study consisted of 32 HCC patients with the following eligibility criteria: (i) portal vein invasion 3/4 and/or hepatic vein invasion 2/3; (ii) received one-shot CDDP via HAI; (iii) received RT for MVI, (iv) a Child–Pugh score ≤ 7; and (v) an Eastern Clinical Oncology Group Performance Status score of 0 or 1. To determine the therapeutic effect, we collected information on patient characteristics and took contrast-enhanced computed tomography at the start of the therapy and every 2 to 4 months after the start of therapy. We evaluated the overall response of the tumor and tumor thrombosis according to modified Response Evaluation Criteria in Solid Tumors. We assessed patient data using the Mann–Whitney U and Fisher exact tests and evaluated overall survival and progression-free survival using the log-rank test.ResultsThe overall response rate at the first evaluation performed a median of 1.4 weeks after HAI was 16% for the main intrahepatic tumor and 59% for the MVI. The best responses were the same as those of the first-time responses. The duration of median survival was 8.6 months, and progression-free survival of the main intrahepatic tumor was 3.2 months. Predictive factors for overall survival were the relative tumor volume in the liver and the first therapeutic response of MVI. There were no severe adverse events or radiation-induced hepatic complications.ConclusionsOne-shot CDDP via HAI and RT were well tolerated and showed immediate and favorable control of MVI. Thus, this combination shows potential as a bridging therapy to systemic chemotherapy.

Tumor Treating Fields Concomitant with Sorafenib in Advanced Hepatocellular Cancer: Results of the HEPANOVA Phase II Study.

Simple SummaryAdvanced hepatocellular carcinoma (HCC) is an aggressive liver cancer with limited treatment options and poor prognosis. Tumor-Treating Fields (TTFields) are electric fields that disrupt cancer cell division and are approved for glioblastoma and mesothelioma treatment. Laboratory research and clinical data from other solid tumor types provided a rationale to investigate whether TTFields combined with a standard treatment (sorafenib) was effective and well tolerated in advanced HCC, with the aim of ultimately improving treatment for these patients. Overall, 27 patients with large tumors and advanced disease were included in this study. Results showed that TTFields with sorafenib reduced the tumor size in 9.5% of patients compared with 4.5% in other studies examining sorafenib alone and was well tolerated. Reduction of tumor size was even better in patients who received TTFields for ≥12 weeks (18%). Results support further investigation of TTFields used with sorafenib in a larger phase III clinical study.Advanced hepatocellular carcinoma (HCC) is an aggressive disease associated with poor prognosis. Tumor Treating Fields (TTFields) therapy is a non-invasive, loco-regional treatment approved for glioblastoma and malignant pleural mesothelioma. HCC preclinical and abdominal simulation data, together with clinical results in other solid tumors, provide a rationale for investigating TTFields with sorafenib in this patient population. HEPANOVA was a phase II, single arm, historical control study in adults with advanced HCC (NCT03606590). Patients received TTFields (150 kHz) for ≥18 h/day concomitant with sorafenib (400 mg BID). Imaging assessments occurred every 12 weeks until disease progression. The primary endpoint was the overall response rate (ORR). Safety was also evaluated. Patients (n = 27 enrolled; n = 21 evaluable) had a poor prognosis; >50% were Child–Turcotte–Pugh class B and >20% had a baseline Eastern Clinical Oncology Group performance status (ECOG PS) of 2. The ORR was higher, but not statistically significant, for TTFields/sorafenib vs. historical controls: 9.5% vs. 4.5% (p = 0.24), respectively; all responses were partial. Among patients (n = 11) with ≥12 weeks of TTFields/sorafenib, ORR was 18%. Common adverse events (AEs) were diarrhea (n = 15/27, 56%) and asthenia (n = 11/27, 40%). Overall, 19/27 (70%) patients had TTFields-related skin AEs; none were serious. TTFields/sorafenib improved response rates vs. historical controls in patients with advanced HCC, with no new safety concerns or related systemic toxicity.

Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus minimally invasive esophagectomy for resectable esophageal adenocarcinoma, a randomized controlled trial (ROBOT-2 trial)

BackgroundFor patients with esophageal adenocarcinoma or cancer of the gastroesophageal junction, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment with curative intent. Both conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison exists between MIE and RAMIE in the Western World for patients with esophageal adenocarcinoma.MethodsThis is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group superiority trial. All adult patients (age ≥ 18 and ≤ 90 years) with histologically proven, surgically resectable (cT1-4a, N0–3, M0) esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 218) with resectable esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction are randomized to either RAMIE (n = 109) or MIE (n = 109). The primary outcome of this study is the total number of resected abdominal and mediastinal lymph nodes specified per lymph node station.ConclusionThis is the first randomized controlled trial designed to compare RAMIE to MIE as surgical treatment for resectable esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction in the Western World. The hypothesis of the proposed study is that RAMIE will result in a higher abdominal and mediastinal lymph node yield specified per station compared to conventional MIE.Short-term results and the primary endpoint (total number of resected abdominal and mediastinal lymph nodes per lymph node station) will be analyzed and published after discharge of the last randomized patient within this trial.Trial registrationClinicalTrials.gov Identifier: NCT04306458. Registered 13th March 2020, https://clinicaltrials.gov/ct2/show/NCT04306458; Date of first enrolment 18.01.2021; Target sample size 218; Recruitment status: Recruiting; Protocol version 2; Issue date 10.03.2020; Rev. 02.02.2021; Authors ET, PCvdS, PPG.

Patient-reported and clinician-rated performance status and general health among women with gynecologic cancers on palliative chemotherapy.

e24128 Background: Oncologists’ perceptions of patients’ performance status (PS) and general health are key determinants of eligibility for chemotherapy and clinical trials. We sought to examine correlations between patient-reported and clinician-rated Eastern Clinical Oncology Group PS (ECOG-PS) and general health status (EQ5D) in women with incurable recurrent gynecologic cancers, as well as step counts from accelerometry as a proxy for objective PS. Methods: We used baseline data from a randomized trial evaluating a mobile health intervention that collects patient-reported outcomes and passive smartphone data and provides tailored symptom management advice. Half of participants also received a wearable accelerometer. We calculated Pearson correlations to determine agreement between ECOG-PS and EQ-5D assessments in patient-clinician dyads. We also calculated the median (IQR) step counts among a subset of women with ≥7 days of ≥8 hours wear time. Results: Data from 78 patient-clinician dyads demonstrated a moderate correlation between patient-reported and clinician-rated ECOG-PS (r = .47; P< .000). Among dyads, 38 (49%) had perfect agreement; 36 (46%) had higher patient-reported ECOG-PS, indicating more patient-reported functional limitations, compared with clinician reports; and 4 (5%) had lower patient-reported ECOG-PS. Comparisons between patient-clinician ratings of EQ-5D subscales indicated moderate agreement for mobility (r = 0.44; P< .001), pain/discomfort (r = 0.45; P< .001), and usual activities (r = 0.36; P= .002); and weak or no agreement for anxiety/depression (r = 0.31; P= .007) and self-care (r = 0.02; P> .05). Participants’ daily step counts varied widely (median = 5,511 steps, IQR = 3,784, range 1,736-13,961) and were not associated with patients’ or clinicians’ ECOG-PS estimates (r = -.12; P= 0.44 and r = -0.03; P= 0.84) or patient-reported mobility (r = -0.10; P =0.51). Conclusions: Among women with incurable gynecologic cancers, patients’ and clinicians’ perceptions of patients’ ECOG-PS were moderately correlated, although 46% of clinician ratings were more optimistic than patients’ ratings. There was also moderate agreement between dyads for mobility and pain/discomfort. Patients’ step counts were not correlated with ECOG-PS or patient-reported mobility. Future studies should examine these measures longitudinally to determine which is the most sensitive predictor of clinical outcomes. Clinical trial information: NCT03022032 .

Non-placement versus placement of a drainage tube around the cervical anastomosis in McKeown esophagectomy: study protocol for a randomized controlled trial

BackgroundEsophagectomy with extended lymphadenectomy remains the mainstay of treatment for localized esophageal cancer. Currently, transthoracic and abdominal esophagectomy with cervical anastomosis (McKeown esophagectomy) is a frequently used technique in Japan. However, cervical anastomosis is still an invasive procedure with a high incidence of anastomotic leakage. The use of a drainage tube to treat anastomotic leakage is effective, but the routine placement of a closed suction drain around the anastomosis at the end of the operation remains controversial. The objective of this study is to evaluate the postoperative anastomotic leakage rate, duration to oral intake, hospital stay, and analgesic use with nonplacement of a cervical drainage tube as an alternative to placement of a cervical drainage tube.MethodsThis is an investigator-initiated, investigator-driven, open-label, randomized controlled parallel-group, noninferiority trial. All adult patients (aged ≥20 and ≤85 years) with histologically proven, surgically resectable (cT1–3 N0–3 M0) squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid squamous cell carcinoma of the intrathoracic esophagus, and European Clinical Oncology Group performance status 0, 1, or 2 are assessed for eligibility. Patients (n = 110) with resectable esophageal cancer who provide informed consent in the outpatient clinic are randomized to either nonplacement of a cervical drainage tube (n = 55) or placement of a cervical drainage tube (n = 55).The primary outcome is the percentage of Clavien–Dindo grade 2 or higher anastomotic leakage.DiscussionThis is the first randomized controlled trial comparing nonplacement versus placement of a cervical drainage tube during McKeown esophagectomy with regards to the usefulness of a drain for anastomotic leakage. If our hypothesis is correct, nonplacement of a cervical drainage tube will be recommended because it is associated with a similar anastomotic leakage rate but less pain than placement of a cervical drainage tube.Trial registrationUMIN-CTR, 000031244. Registered on 1 May 2018.

Retrospective analysis of outcomes and prognostic factors of chemotherapy for small-cell lung cancer.

BackgroundSmall-cell lung cancer (SCLC) is responsive to initial chemotherapy but becomes resistant to cytotoxic drugs. The aim of this study was to evaluate what proportion of patients with SCLC had received the first- and further-line chemotherapy and which patients had benefited from chemotherapy.MethodsWe retrospectively reviewed medical records of patients with SCLC who had been treated with the best supportive care alone and the first-, second-, or third-line chemotherapy at the Osaka Police Hospital from June 2007 until March 2015.ResultsAmong 145 patients diagnosed with SCLC and eligible for analysis, 118 patients received chemotherapy. We added five patients who initiated the second-line chemotherapy during the study period at our institution. Sixty-five and 31 patients received the second- and third-line chemotherapies, respectively. Multivariate logistic regression analysis detected age ≥75 years (odds ratio, 2.80; 95% confidence interval, 1.01–7.75; P=0.047) and European Clinical Oncology Group Performance Status (ECOG PS) 3–4 (14.3; 4.86–41.9; P<0.01) as factors disturbing the introduction of chemotherapy. Multivariate Cox hazard analyses also detected ECOG PS 2–4 (3.34; 2.00–5.58; P<0.01) as a factor decreasing overall survival after the first-line chemotherapy, and C-reactive protein level ≥1.0 mg/dL (2.67; 1.30–5.47; P<0.01) and progression-free survival after the first-line chemotherapy ≥6 months (2.85; 1.50–5.43; P<0.01) as factors influencing overall survival after the second-line chemotherapy.ConclusionApproximately two-thirds and one-third of the patients who receive chemotherapy proceed to the second- and third-line chemotherapies, respectively. Several factors, such as age, ECOG PS, C-reactive protein level, and progression-free survival after previous treatment may be useful when considering the introduction of further-line chemotherapy.

Combination chemotherapy of gemcitabine and vinorelbine for pretreated non-small-cell lung cancer: a retrospective study.

BackgroundAdvanced non-small-cell lung cancer (NSCLC) eventually progresses after first-line chemotherapy, and usually requires salvage treatment. Although neither gemcitabine nor vinorelbine is approved as a candidate drug in the second- or further-line for NSCLC, they can be alternative drugs in terms of anti-tumor effects and toxicities. Actually, in our institution, we often use a combination of these two anti-tumor drugs in our daily practice.MethodsWe retrospectively reviewed 85 patients with advanced NSCLC who had received combination chemotherapy of gemcitabine and vinorelbine after a platinum-based regimen from June 2007 to June 2014 in Osaka Police Hospital, and performed Cox proportional hazard analyses in order to detect predictive factors for progression-free survival (PFS).ResultsPatient characteristics included a mean age of 65.5 years, 56 males, 54 adenocarcinoma, 53 European Clinical Oncology Group performance status 0–1. Thirteen and 35 patients received the study treatment as the second- and third-line treatment, respectively. The overall response rate, disease control rate, PFS, and overall survival were 4.7% (95% confidence interval 1.3%–11.6%), 30.6% (21.0%–41.5%), 2.1 months (1.7–2.8 months), and 6.9 months (5.0–11.0 months). Twenty-one and six patients experienced grade 4 neutropenia and febrile neutropenia, respectively. European Clinical Oncology Group performance status 0–1 was detected as a factor predicting longer PFS by univariate (hazard ratio, 1.63; 95% confidence interval, 1.28–2.08; P<0.001) and multivariate (1.65, 1.27–2.14, P<0.001) analyses.ConclusionThis combination was ineffective and harmful to pretreated patients with NSCLC. We do not recommend this regimen as a later-line treatment option.

Phase II study of S-1 monotherapy in paclitaxel- and cisplatin-refractory gastric cancer

S-1 is a fourth-generation oral fluoropyrimidine that was developed to mimic the effects achieved with protracted continuous infusion of 5-fluorouracil (5-FU). This phase II study evaluated the efficacy and safety of S-1 salvage chemotherapy in patients with paclitaxel- and cisplatin-refractory gastric cancer. The primary end point was progression-free survival; secondary end points were overall survival, safety, and clinical benefit. Patients were eligible for the study if they had histologically documented gastric adenocarcinoma previously treated with paclitaxel and cisplatin, age > or = 18 years, Eastern Clinical Oncology Group performance status < or =2, adequate organ function, and no evidence of gastrointestinal obstruction or passage disturbance. Patients were treated with a dose of S-1 based on body surface area (BSA) as follows: BSA < 1.25 m(2), 80 mg/day; 1.25 < or = BSA < 1.5 m(2), 100 mg/day; BSA > or= 1.5 m(2), 120 mg/day. The total dose was divided in two and administered twice daily for 4 weeks followed by a 2-week rest period. Of the 53 patients enrolled in this study, 49 were evaluable. A total of 190 chemotherapy cycles were administered, and the median number of cycles was 2. Five patients (9.4%) had a partial response, and 18 (34%) had stable disease. Median progression-free survival and overall survival were 4.9 and 10.4 months, respectively. Grade 3/4 hematological toxicities included neutropenia in six patients (11%) but no cases of febrile neutropenia were found. Most of the non-hematological toxicities were diarrhea, asthenia, and mucositis, but none reached grade 3 or grade 4 in severity. Improvement of pain was observed in 17 patients (32.1%). S-1 monotherapy provides active and safe salvage chemotherapy for patients with advanced gastric cancer who have been previously treated with paclitaxel and cisplatin.

Estimation of Patient Preference-Based Utility Weights from the Functional Assessment of Cancer Therapy—General

Objectives The goal of this study was to estimate an algorithm to convert responses to the Functional Assessment of Cancer Therapy—General (FACT-G) to time trade-off (TTO) utilities based on utilities for current health elicited from cancer patients. Methods Data for 1433 cancer patients were randomly separated into construction and validation samples. Four FACT-G questions were selected for inclusion based on correlation with Eastern Clinical Oncology Group—Performance Status (ECOG-PS) scores and TTO utilities. Item response theory was used to collapse response categories. Ordinary least squares regression with the constant constrained to one was used to estimate the algorithm. Results The algorithm estimated mean utility for the full validation sample within three points of observed mean utility (0.805 vs. 0.832, P < 0.01). Mean utilities were wellpredicted (mean absolute difference < 0.03, P > 0.05) for most subgroups defined by ECOG-PS and Short Form-36 physical functioning scores, and responses to the FACT-G overall quality of life item. Nevertheless, the algorithm systematically overpredicted utilities for poorer health states. Conclusion A FACT-G-based algorithm of cancer patient utilities was developed that estimates group mean utility scores with accuracy comparable to other indirect preference-based measures of health-related quality of life. Patient-based preferences for health outcomes of cancer treatment may be useful in multiple situations, such as managing resources within cancer centers and in understanding health states preferences among cancer experienced patients before and after treatment.

Gefitinib treatment for non-small cell lung cancer -- a study including patients with poor performance status.

Gefitinib is effective in the treatment of advanced non-small cell lung cancer (NSCLC). However, most studies have only investigated patients who have good performance status or are evaluable. This study evaluated the efficacy of geftinib in a consecutive series of patients with NSCLC. The treatment response of all gefitinib-treated NSCLC patients from November 2001 to September 2003 at a single medical institute was retrospectively evaluated. All patients receiving at least 1 dose of gefitinib during the study period were included. A total of 66 NSCLC patients were treated, including 22 patients with Eastern Clinical Oncology Group performance status 3 or 4. No prior chemotherapy had been given in 14 patients because of their personal preference or poor general condition. The duration of treatment ranged from 1 day to 19.3 months (median, 2.5 months). The partial remission rate was 15.2% and the stable disease rate was 25.8%. The median survival for all patients was 5.9 months and the 1-year survival rate was 27.9%. Symptom improvement and response correlated well to survival. Female gender, non-smoking status, and performance status of 0-2 were associated with better survival. The disease control rate was 22.7% in patients with performance status of 3-4. Gefitinib can be recommended for the treatment of advanced NSCLC in patients for whom standard chemotherapy is not an option. Further study is required to determine the optimal selection criteria of patients and the timing of starting therapy.