Monotherapy for Low-Risk Gestational Trophoblastic Neoplasia with score 5-6

Objective To investigate efficacy and safety of monotherapy in low-risk gestational trophoblastic neoplasia (GTN) patients with a high FIGO/WHO prognostic score of 5–6. Methods The low-risk GTN patients with a high FIGO/WHO prognostic score of 5–6 from January 2012 to December 2019 were enrolled. The study is a retrospective report. Real-world data were used to analyze the efficacy and safety of single-agent chemotherapy and combination chemotherapy in patients with a high FIGO/WHO prognostic score of 5–6. Results A total of 224 patients were enrolled, including 75 cases (33.5%) with a FIGO/WHO prognostic score of 5–6. Complete remission was in all patients. Among the 29 cases with a FIGO/WHO prognostic score of 5–6 taking single-agent chemotherapy, 22 cases (75.9%) developed drug resistance, the number of chemotherapy courses was 7.8±2.1, and the number of chemotherapy courses required for β-hCG to return to normal was 5.4±1.8. Among the 46 cases taking combination chemotherapy, 7 patients (15.2%) developed drug resistance, the number of chemotherapy courses was 7.4±2.0, and the number of chemotherapy courses required for β-hCG to return to normal was 4.8±1.6. There was a statistically significant difference in the drug resistance rate between these two subgroups (P < 0.05), but there was not statistically significant difference in the total number of chemotherapy courses or number of chemotherapy courses required for β-hCG to return to normal (<2mIU/ml) (P < 0.05). Conclusion Monotherapy showed remarkable advantages in low-risk GTN patients with a FIGO/WHO prognostic score of 5–6.

Immune Checkpoint Inhibitors Plus Single-Agent Chemotherapy for Advanced Non-Small-Cell Lung Cancer After Resistance to EGFR-TKI

PurposePlatinum-based chemotherapy remains the classic treatment option for patients with advanced non-small-cell lung cancer (NSCLC) who progress while receiving treatment with epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs). In this study, we analyzed real-world outcomes of treatment with immune checkpoint inhibitors (ICIs) combined with platinum-free chemotherapy in patients with NSCLC after developing resistance to EGFR-TKIs.MethodsThis retrospective study included patients with mutation-positive NSCLC after developing resistance to EGFR-TKIs. Patients who received chemotherapy alone plus ICIs with or without anti-angiogenic drugs (cohort A) or platinum-based chemotherapy (cohort B) between February 2019 and August 2020 were enrolled. Clinical characteristics, EGFR mutation status, response to therapy, and adverse events (AEs) were retrospectively analyzed.ResultsSeventeen patients were eligible and included in the analysis, including 8 in cohort A and 9 in cohort B. After a median follow-up of 7.6 months, the median progression-free survival was 6.5 months [95% confidence interval (CI), 6.1 to 7.0] in cohort A and 3.6 months (95% CI, 1.3–5.8) in cohort B (hazard ratios, 0.22; 95% CI, 0.05–0.93; P = 0.039). The overall response and disease control rates were 50% and 100% in cohort A, and 22% and 89% in cohort B, respectively. Adverse events of grade 3 or higher occurred in 25% of the patients in cohort A and in 33.3% of the patients in cohort B.ConclusionICIs plus platinum-free, single-agent chemotherapy provides promising progression-free survival and overall response rate benefit, along with a low rate of severe AEs in patients with EGFR-TKI-resistant advanced NSCLC.

Chemotherapy and Targeted Therapy for Patients With Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer That is Either Endocrine-Pretreated or Hormone Receptor–Negative: ASCO Guideline Update

PURPOSE This guideline updates recommendations of the ASCO guideline on chemotherapy and targeted therapy for patients with human epidermal growth factor receptor 2–negative metastatic breast cancer (MBC) that is either endocrine-pretreated or hormone receptor (HR)–negative. METHODS An Expert Panel conducted a targeted systematic literature review guided by a signals approach to identify new, potentially practice-changing data that might translate into revised guideline recommendations. RESULTS The Expert Panel reviewed abstracts from the literature review and retained 14 articles. RECOMMENDATIONS Patients with triple-negative, programmed cell death ligand-1–positive MBC may be offered the addition of immune checkpoint inhibitor to chemotherapy as first-line therapy. Patients with triple-negative, programmed cell death ligand-1–negative MBC should be offered single-agent chemotherapy rather than combination chemotherapy as first-line treatment, although combination regimens may be offered for life-threatening disease. Patients with triple-negative MBC who have received at least two prior therapies for MBC should be offered treatment with sacituzumab govitecan. Patients with triple-negative MBC with germline BRCA mutations previously treated with chemotherapy may be offered a poly (ADP-ribose) polymerase inhibitor rather than chemotherapy. Patients with HR-positive human epidermal growth factor receptor 2–negative MBC for whom chemotherapy is being considered should be offered single–agent chemotherapy rather than combination chemotherapy, although combination regimens may be offered for highly symptomatic or life-threatening disease. Patients with HR-positive MBC with disease progression on an endocrine agent may be offered treatment with either endocrine therapy with or without targeted therapy or single-agent chemotherapy. Patients with HR-positive MBC with germline BRCA mutations no longer benefiting from endocrine therapy may be offered a poly (ADP-ribose) polymerase inhibitor rather than chemotherapy. No recommendation regarding when a patient's care should be transitioned to hospice or best supportive care alone is possible. Additional information is available at www.asco.org/breast-cancer-guidelines .

Disparate Use of Chemoradiation in Elderly Patients With Localized Anal Cancer

Background: The incidence of squamous cell carcinoma of the anus (SCCA) is increasing, particularly among the elderly (age ≥65 years). We sought to compare patterns of care for the treatment of SCCA in elderly versus nonelderly patients. Methods: Data for patients with stages I–III SCCA diagnosed from 2004 through 2015 were obtained from the National Cancer Database. Patients were categorized as having received standard-of-care (SOC) chemoradiation (CRT) with multiagent chemotherapy, non-SOC therapy, palliative therapy, or no treatment. Differences in treatment groups were tested using the chi-square test. We used logistic regression to identify predictors of SOC CRT and multiagent versus single-agent chemotherapy in patients receiving CRT. Propensity score matching was used to compare overall survival (OS) in elderly patients receiving multiagent versus single-agent chemotherapy for those receiving CRT. Results: We identified 9,156 elderly and 17,640 nonelderly patients. A lower proportion of elderly versus nonelderly patients (54.5% vs 65.0%; P<.0001) received SOC CRT than other treatments or no treatment. In multivariate analysis, elderly patients were 38% less likely than nonelderly patients to receive SOC CRT (odds ratio, 0.62; 95% CI, 0.58–0.65; P<.0001). A higher proportion of the elderly were treated with single-agent versus multiagent chemotherapy (16.9% vs 11.8%; P<.0001), which resulted in a >1.5-fold increase in the likelihood of elderly patients receiving single-agent chemotherapy (odds ratio, 1.52; 95% CI, 1.39–1.66) in multivariate analysis. After propensity score matching, 3-year OS was higher in elderly patients who received CRT with multiagent versus single-agent chemotherapy (77.1% vs 67.5%; hazard ratio, 0.78; 95% CI, 0.68–0.89; P=.0002). Conclusions: In this comprehensive study of patients with stages I–III SCCA, elderly patients were less likely than nonelderly patients to receive SOC CRT. The low proportion of elderly patients receiving SOC CRT with multiagent chemotherapy for localized anal cancer suggests that the optimal treatment approach for this vulnerable population remains undefined.

Impact of Perioperative Chemotherapy on Survival Outcomes Among Patients with Metastatic Colorectal Cancer to the Liver

IntroductionWhile surgical resection for primary tumor and distant metastases is recommended among individuals with resectable colorectal liver metastases, the role and timing of perioperative systemic therapy is not yet defined.Materials and MethodsThe National Cancer Database was queried for patients diagnosed with metastatic colorectal adenocarcinoma with isolated liver metastases between 2004 and 2016. We evaluated the overall survival (OS) based on the perioperative chemotherapy status using Kaplan-Meier estimates and multivariable cox regression analyses.ResultsA total of 6,883 patients with metastatic CRC and liver metastases were included, within which 6,042 (87.8%) were treated with surgery and chemotherapy, and 841(12.2%) were treated with surgery only. We found that patients who were treated with surgery and chemotherapy had better OS compared to patients who were treated with surgery only (median OS 42.9 months vs 6.4 months, P<0.001). On multivariable analysis, chemotherapy was associated with better OS (HR 0.30; 95% CI: 0.275 - 0.328; P<0.001).We also found that patients who received multiagent chemotherapy had better OS compared to patients who received single-agent chemotherapy (median OS 43.7 months vs 36.1 months, P<0.001), patients who received neoadjuvant chemotherapy had better OS compared to patients who received adjuvant chemotherapy (median OS 48.6 months vs 38.6 months, P<0.001).ConclusionPatients with CRC with isolated liver metastases who were treated with perioperative chemotherapy had significant improvement in OS compared to patients who didn’t receive chemotherapy. Also, neoadjuvant chemotherapy had better OS compared to adjuvant chemotherapy, and multiagent chemotherapy had better OS compared to single-agent chemotherapy.

The Use of Single-agent Versus Multiple-agent Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Rectal Cancer

Purpose: The use of concurrent chemoradiotherapy is frequently recommended in the treatment of locally advanced rectal cancer however the ideal chemotherapy regimen remains unknown and there is variability in chemotherapy agents used among different institutions. We sought to examine differences in overall survival between patients receiving single versus multiple-agent concurrent chemoradiotherapy.Methods: The National Cancer Database was used to identify 31,025 patients with rectal cancer who received concurrent chemoradiotherapy between 01/2006 through 12/2016. We compared patients who received single-agent chemotherapy with those who received multiple-agent concurrent chemoradiotherapy. The primary outcome of interest was overall survival. The groups were compared using univariate analysis and Cox proportional hazard models to adjust for potential confounding factors. Results: 18,544 patients received single-agent and 12,481 patients received multiple-agent chemotherapy. The former were older with more comorbidities as evidenced by their higher Charlson-Deyo Scores. Those receiving multiple-agent chemotherapy were more likely to have clinical Stage III disease (52.9% vs 43.3%, p<0.001) and less likely to have well-differentiated cancer (6.9% vs 7.7%, p<0.001). The rates of negative resection margin were identical (p=0.225) between the two groups. On multivariable analysis after adjusting for comorbidities, radiation dose, and resection margins, single-agent chemotherapy was associated with worse overall survival (HR 1.09, 95% CI 1.057-1.124, p<0.001). Conclusion: Multiple-agent chemoradiotherapy is associated with improved overall survival in locally advanced rectal cancer, however chemotherapy regimen does not affect resection margins. The modest overall survival benefit with multiple agent chemotherapy must be balanced with the potential associated toxicity.

The Curative Effect of a Second Curettage in Low-Risk Gestational Trophoblastic Neoplasia

Background: Gestational trophoblastic neoplasia (GTN), despite its widespread metastases, is a very common cancer in women that is curable. Although the GTN cases show a good response to chemotherapy, in an effort to reduce toxic drug exposure, the second curettage has been suggested for some patients. In the current study, we have aimed to compare the benefits of the second curettage in comparison with single-agent chemotherapy for low-risk GTN patients. Methods: This retrospective observational study was carried out on GTN patients admitted to the gynecology department of Imam Khomeini Hospital in Ahvaz. The demographic profile of all participants was extracted. Patients&#39; hospitalization records were also extracted from the files. Patients with an endometrial thickness above 10 mm were treated with re-curettage. The &beta; hCG clearance time was estimated by the Kaplan Meier plot. Results: In the present study, 148 patients with low-risk GTN stage 1 were studied. The time required for &beta;-hCG clearance in patients undergoing re-curettage was significantly lower than the chemotherapy receiving group (7 months vs. 10 months, p &lt;0.0001). More than 50% of patients treated by re- curettage without needing chemotherapy. Moreover, the other 50% cases needed chemotherapy the number of courses was significantly lower than those received single-agent chemotherapy alone (p &lt;0.0001). The baseline &beta;-hCG levels were significantly lower in those who did not need chemotherapy (p = 0.012). &beta;-hCG resolution occurred more rapidly in patients undergoing re-curettage alone, while, those who received only chemotherapy had a longer duration for &beta;-hCG clearance. Conclusion: In general, the findings of this study showed that re-curettage could be used effectively in the treatment of GTN following molar pregnancy. This treatment reduces or eliminates the need for chemotherapy. Our findings also showed that the initial level of &beta;-hCG could be considered as a predictive factor in response to curettage.