Risk of mineralocorticoid excess syndrome with CYP17 inhibitor abiraterone in prostate cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15140-e15140
Author(s):  
Sandy Ann Itwaru ◽  
Arun Gopal ◽  
Omer Bashir ◽  
Joomee Shim ◽  
Xiaolei Zhu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Side Effects ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Abiraterone Acetate ◽  
Fixed Effects Model ◽  
Starting Dose ◽  
Grade 3 ◽  
American Society

e15140 Background: CYP17 inhibitor abiraterone acetate has been used for the treatment of patients with metastatic castration-refractory prostate cancer (CRPC). Hypertension, hypokalemia and edema are the major side effects associated with its use, and may be secondary to the excess of mineralocorticoids due to CYP17 inhibition. We performed a systematic review and meta-analysis of published clinical trials to determine the effect of abiraterone on the development of these side effects. Methods: Databases including Pubmed (July, 1966 to July, 2011), Web of Science, and abstracts presented at the American Society of Clinical Oncology meetings from 2008 to 2011 were searched to identify relevant studies. Eligible studies were prospective clinical trials of patients with prostate cancer receiving abiraterone acetate at the starting dose of 1,000 mg daily with available data on hypertension, hypokalemia and edema. Incidence and relative risk (RR) were calculated using a random-effects or fixed-effects model. Results: A total of seven studies including 1,387 patients with CRPC were selected for analysis. The incidences of all-grade hypertension, hypokalemia, and edema were 13.3% (95% CI: 8.3 to 20.5%), 31.4 % (95% CI: 12.5-59.5%), and 23.4 % (95% CI: 15.6-33.5%) respectively. The incidences of high-grade (grade 3 and above) toxicity were low, with a rate of 3.6% (95% CI: 2.6-5.1%), 2.8 % (95% CI: 0.9 to 8.2%), and 2.1% (95%CI: 1.3-3.2%) for hypertension, hypokalemia, and edema respectively. The risk of hypertension and edema did not change with and without the addition of prednisone (p=0.48 and p=0.40, respectively); however, the risk of hypokalemia was significantly reduced with the addition of prednisone (p = 0.003). In comparison with prednisone alone, the addition of abiraterone did not increase the risk of hypertension (RR 1.22, 95% CI: 0.82 – 1.83, p=0.31), but significantly increased the risk of edema (RR 1.36, 95% CI: 1.10-1.69, p=0.004) and hypokalemia (RR 2.04, 95% CI: 1.42–2.92, p<0.001). Conclusions: There were differential effects of abiraterone on the development of hypertension, hypokalemia, and edema in patients with advanced prostate cancer. Further studies are recommended for optimal treatment.

A Systematic Review and Meta-Analysis about the Effect of Bisphosphonates on the Risk of Skeletal-Related Event in Men with Prostate Cancer

2020 ◽  
Vol 20 (13) ◽  
pp. 1604-1612
Author(s):  
Congcong Wu ◽  
Hua Jiang ◽  
Jianghua Chen
Keyword(s):  
Prostate Cancer ◽  
Fixed Effects ◽  
Data Extraction ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Control Group ◽  
Fixed Effects Model ◽  
Related Event ◽  
Mineral Density ◽  
Skeletal Related Event

Background: Although the adjuvant therapy of bisphosphonates in prostate cancer is effective in improving bone mineral density, it is still uncertain whether bisphosphonates could decrease the risk of Skeletal- Related Event (SRE) in patients with prostate cancer. We reviewed and analyzed the effect of different types of bisphosphonates on the risk of SRE, defined as pathological fracture, spinal cord compression, radiation therapy to the bone, surgery to bone, hypercalcemia, bone pain, or death as a result of prostate cancer. Methods: A systemic literature search was conducted on PubMed and related bibliographies. The emphasis during data extraction was laid on the Hazard Ratio (HR) and the corresponding 95% Confidence Interval (CI) from every eligible Randomized Controlled Trial (RCT). HR was pooled with the fixed effects model, and preplanned subgroup analyses were performed. Results: 5 RCTs (n = 4651) were included and analyzed finally after screening 51 articles. The meta-analysis of all participants showed no significant decrease in the risk of SRE when adding bisphosphonates to control group (HR = 0.968, 95% CI = 0.874 - 1.072, p = 0.536) with low heterogeneity (I2 = 0.0% (d.f. = 4) p = 0.679). There was no significant improvement on SRE neither in the subgroups with Metastases (M1) or Castration-Sensitive Prostate Cancer (CSPC) (respectively HR = 0.968, 95% CI = 0.874 - 1.072, p = 0.536, I2 = 0.0% (d.f. = 4) p = 0.679; HR = 0.954, 95% CI = 0.837 - 1.088, p = 0.484, I2 = 0.0% (d.f. = 3) p = 0.534). Conclusion: Our study demonstrated that bisphosphonates could not statistically significantly reduce the risk of SRE in patients with prostate cancer, neither in the subgroups with M1 or CSPC.

Systemic therapy for nonmetastatic castrate-resistant prostate cancer (M0 CRPC): A systematic review and network meta-analysis (NMA).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 113-113
Author(s):  
Ellen Cusano ◽  
Richard M. Lee-Ying ◽  
Devon J. Boyne ◽  
Darren Brenner ◽  
Marcus Vaska
Keyword(s):  
Fixed Effects ◽  
Meta Analysis ◽  
Cochrane Collaboration ◽  
Similar Efficacy ◽  
Risk Of Bias ◽  
Fixed Effects Model ◽  
Castrate Resistant Prostate Cancer ◽  
Grade 3 ◽  
Castrate Resistant ◽  
The Cochrane Collaboration

113 Background: The treatment landscape for M0 CRPC has changed following the demonstrated efficacy of new agents in recent randomized control trials (RCT). However, the comparative effectiveness of these novel agents is unknown. This NMA indirectly compared the efficacy and safety of available therapies for M0 CRPC. Methods: A literature search of MEDLINE (Ovid), EBM Reviews, HealthSTAR, PubMed, PubMed Central, CINAHL, and TRIP Database was performed. Studies were screened by two independent reviewers. Hazard ratios (HR) and confidence intervals were extracted for the primary outcome metastasis-free survival (MFS) and the secondary outcomes overall survival (OS) and grade 3 or higher adverse events (AE). Bone MFS was used as a surrogate for MFS when MFS was not reported. Risk of bias was assessed using the Cochrane Collaboration tool. A Bayesian NMA was performed using a fixed-effects model. Results: Four RCT were analyzed (n=5549). Each trial compared either apalutamide (APA), enzalutamide (ENZA), darolutamide (DARO), or denosumab (DENO) plus androgen deprivation therapy (ADT) to placebo plus ADT. Risk of bias was low. For MFS, APA and ENZA had similar efficacy (Table), and Surface Under the Cumulative Ranking Analysis demonstrated a 59% probability that APA was preferred for MFS, followed by ENZA (41%). There was a trend for improved OS for APA, DARO and ENZA, but no meaningful differences between these agents. APA, ENZA, and DARO had a similar risk of AEs and all had a greater risk of AEs compared to DENO. Conclusions: APA and ENZA appear to be the most efficacious treatments for MFS in M0 CRPC, though more data for OS is required. Compared to DARO, APA and ENZA’s demonstrated efficacy is not at the expense of added toxicity.[Table: see text]

scholarly journals Combination of Immune Checkpoint Inhibitors and Radiotherapy for Advanced Non-Small-Cell Lung Cancer and Prostate Cancer: A Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Zexi Xu ◽  
Jia Feng ◽  
Yiming Weng ◽  
Yao Jin ◽  
Min Peng
Keyword(s):  
Prostate Cancer ◽  
Lung Cancer ◽  
Cell Lung Cancer ◽  
Immune Checkpoint ◽  
Fixed Effects ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
Clinical Manifestations ◽  
Grade 3

Objectives. Immune checkpoint inhibitors (ICI) combined with radiotherapy (RT) have emerged as a breakthrough therapy in the treatment of various cancers. The combination has a strong rationale, but data on their efficacy and safety are still limited. Hence, we comprehensively searched the database and performed this study to elucidate the clinical manifestations of this combined strategy. Methods. We performed a meta-analysis of randomized trials that compared ICI plus RT with placebo plus RT or ICI alone for the treatment of advanced nonsmall-cell lung cancer (NSCLC) and prostate cancer. The outcomes included overall survival (OS), progression-free survival (PFS), disease control rate (DCR), and treatment-related adverse events. A fixed-effects or random-effects model was adopted depending on between-study heterogeneity. Results. Three trials involving 1584 patients were included. ICI plus RT was significantly associated with improvement of OS (hazard ratio [HR] = 0.81, 95% confidence interval [CI] = 0.70–0.94, P = 0.004 ), PFS (HR = 0.64; 95% CI 0.56–0.72, P < 0.00001 ), and DCR (relative risk [RR] = 1.38; 95% CI 1.03–1.84, P = 0.03 ). A significant predictor for PFS with the combination of ICI and RT was age, as a significant improvement in PFS (HR = 0.49; 95% CI 0.37–0.64, P < 0.00001 ) was observed in NSCLC patients aged under 65 years. In safety analyses, patients receiving ICI plus RT had a significantly higher incidence of dyspnea (RR = 2.43; 95% CI 1.16–5.08, P = 0.02 ) and pneumonitis of grade 3 or higher (RR = 2.78; 95% CI 1.32–5.85, P = 0.007 ). Conclusion. The combination of ICI and RT was associated with improved OS, PFS, and DCR. Patients under 65 years will be the dominant beneficiaries. However, the incidence of dyspnea and pneumonia of grade 3 or higher also increased, which deserves our vigilance.

scholarly journals Randomized Controlled Trials of Early Ambulatory Hydroxychloroquine in the Prevention of COVID-19 Infection, Hospitalization, and Death: Meta-Analysis

2020 ◽  
Author(s):  
Joseph A. Ladapo ◽  
John E. McKinnon ◽  
Peter A. McCullough ◽  
Harvey Risch
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Side Effects ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Exposure Prophylaxis

Objective--To determine if hydroxychloroquine (HCQ) reduces the incidence of new illness, hospitalization or death among outpatients at risk for or infected with SARS-CoV-2 (COVID-19). Design--Systematic review and meta-analysis of randomized clinical trials. Data sources--Search of MEDLINE, EMBASE, PubMed, medRxiv, PROSPERO, and the Cochrane Central Register of Controlled Trials. Also review of reference lists from recent meta-analyses. Study selection--Randomized clinical trials in which participants were treated with HCQ or placebo/standard-of-care for pre-exposure prophylaxis, post-exposure prophylaxis, or outpatient therapy for COVID-19. Methods--Two investigators independently extracted data on trial design and outcomes. Medication side effects and adverse reactions were also assessed. The primary outcome was COVID-19 hospitalization or death. When unavailable, new COVID-19 infection was used. We calculated random effects meta-analysis according to the method of DerSimonian and Laird. Heterogeneity between the studies was evaluated by calculation of Cochran Q and I2 parameters. An Egger funnel plot was drawn to investigate publication bias. We also calculated the fixed effects meta-analysis summary of the five studies. All calculations were done in Excel, and results were considered to be statistically significant at a two-sided threshold of P=.05. Results--Five randomized controlled clinical trials enrolling 5,577 patients were included. HCQ was associated with a 24% reduction in COVID-19 infection, hospitalization or death, P=.025 (RR, 0.76 [95% CI, 0.59 to 0.97]). No serious adverse cardiac events were reported. The most common side effects were gastrointestinal. Conclusion--Hydroxychloroquine use in outpatients reduces the incidence of the composite outcome of COVID-19 infection, hospitalization, and death. Serious adverse events were not reported and cardiac arrhythmia was rare. Systematic review registration--This review was not registered.

Association of risk of febrile neutropenia (FN) with docetaxel in prostate cancer (PC) patients: A meta-analysis of published phase II-III trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21683-e21683
Author(s):  
Blazquez Arroyo Maria ◽  
Antonio Merida Garcia ◽  
David Lora ◽  
Brandon David Bernard ◽  
Lorente David ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Relative Risk ◽  
Phase Ii ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Bone Marrow Involvement ◽  
Risk Groups ◽  
Castration Resistant Prostate Cancer ◽  
Fixed Effects Model

e21683 Background: Reported rates of FN with docetaxel (DTX) in PC patients are variable. This creates uncertainty regard the use of granulocyte colony-stimulating factor primary prophylaxis (G-CSF) in this setting. We conducted a meta-analysis of randomized clinical trials to determine the relative risk (RR) of FN in patients receiving DTX. Methods: To perform this analysis we systematically searched in PUBMED and MEDLINE database the following terms: “DTX”, “randomized clinical trial” and “prostate cancer” only for articles published between January 1996 and August 2016. Phase II-III clinical studies comparing DTX to non-DTX control arms (best supportive care [BSC] including non-cytotoxic therapy or mitoxantrone) for PC were included. The meta-analyses were performed by computing RRs with 95% confidence intervals (CI) using fixed-effects model with the Mantel-Haenszel method. Results: Seven studies (N = 5088 patients) were included. The global incidence of FN in patients treated with DTX was 10.7%. The RR of FN was higher in patients receiving DTX compared to patients did not receive DTX (RR 16.8 [95% CI 10.7; 26.4] p < 0.0001). 6.6% of patients with metastatic castration resistant prostate cancer (CRPC) treated with DTX developed FN, the RR of FN with DTX compared to mitoxantrone was 28.6 (95% CI 5.6; 145.1). 12.4% of patients with hormone-sensitive prostate cancer (HSPC) treated with DTX developed FN, the RR of FN was 15.3 (95% CI 9.6; 24.6) compared to BSC. There was no statistically significant differences in the rate of FN according to the hormone sensitivity (HSPC vs CRPC) (p = 0.7). In most studies the use of G-CSF was at the discretion of the investigator. Conclusions: This meta-analysis shows that DTX is associated with a significant increase in the relative risk of FN in patients with PC. The effectiveness of primary prophylactic G-CSF in this setting has not been fully established. The incidence reported here does not meet the threshold recommended by ESMO and ASCO guidelines for the use of prophylactic G-CSF. Special attention should be given to high risk groups for FN, including elderly patients and those with bone marrow involvement or previous radiotherapy/chemotherapy.

Risk of skin rash with the proteasome inhibitor bortezomib: Updated systematic review and meta-analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9092-9092
Author(s):  
Emily Christine Case ◽  
Shenhong Wu ◽  
John F. Gerecitano ◽  
Mario E. Lacouture
Keyword(s):  
Skin Rash ◽  
Proteasome Inhibitor ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Significant Risk ◽  
Phase Iii ◽  
High Grade ◽  
Fixed Effects Model ◽  
Increased Risk ◽  
American Society

9092 Background: Rash is a common, adverse event to the novel proteasome inhibitor bortezomib (Velcade). Indicated for the treatment of multiple myeloma and mantle cell lymphoma, bortezomib is the first proteasome inhibitor approved by regulatory agencies. Because the incidence of bortezomib-induced skin rash varies widely in published manuscripts, we performed a systematic literature review and meta-analysis to determine the incidence and overall risk. Methods: We searched PubMed and Web of Science databases and abstracts presented at the American Society of Clinical Oncology and The American Society of Hematology annual meetings (1998 to July 2011) to identify relevant clinical studies. Eligible studies included prospective clinical phase II and phase III trials, with data on the incidence of rash in patients taking 1.3mg/m2, 1.5mg/m2, or 1.6 mg/m2 of bortezomib intravenously either weekly or twice weekly. The incidence of rash and relative risk (RR) were calculated using random-effects or fixed-effects model, depending on the heterogeneity of included studies. Results: A total of 2,616 patients with various hematologic and solid malignancies from 35 clinical trials were included for analysis. Among patients receiving twice weekly bortezomib, the summary incidence of all-grade and high-grade rash were 18.8 % (95% CI: 14.9% to 23.5%) and 3.6 % (95% CI: 2.3% to 5.7%), respectively. We found no significant increase in all grade rash incidence with higher doses of bortezomib: 19.3 % (95% CI: 15% to 24.5%) and 20.8% (95% CI: 11.6% to 34.4%) for doses of 1.3 mg/m2 and 1.5 mg/m2, respectively. In addition, bortezomib was associated with an increased risk in both all grade (RR: 19.70, 95% CI: 8.73 to 44.44, p<0.001) and high-grade rash (RR: 5.35, 95% CI: 2.16 to 13.29, p<0.001), compared to controls. Weekly bortezomib is associated with lower risk of rash compared to twice weekly dosing (incidence 3.9% versus 18.8%, p=0.001). Conclusions: Bortezomib is associated with a significant risk of developing rash with a higher risk among patients receiving twice weekly dosage. Management of rash to bortezomib is critical to prevent a negative effect on quality of life and dose modifications, both of which affect clinical outcome.

Pruritus in patients treated with targeted cancer therapies: Systematic review and meta-analysis.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e13571-e13571
Author(s):  
Courtney J. Ensslin ◽  
Alyx C. Rosen ◽  
Shenhong Wu ◽  
Mario E. Lacouture
Keyword(s):  
Systematic Review ◽  
Targeted Therapies ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Significant Risk ◽  
Cancer Therapies ◽  
Fixed Effects Model ◽  
Increased Risk ◽  
Targeted Cancer Therapies ◽  
American Society

e13571 Background: Pruritus is a disabling symptom that has been anecdotally described in patients treated with targeted cancer therapies, and reports on its incidence vary. The overall risk to develop pruritus in these patients has not been systematically ascertained. We conducted a systematic review and meta-analysis of the literature to determine the incidence and risk of developing pruritus among patients treated with targeted therapies. Methods: Databases from PubMed and Web of Science from January 1998 until July 2012 and abstracts presented at the American Society of Clinical Oncology annual meetings from 2004 through 2012 were searched to identify relevant studies. The incidence and relative risk (RR) of pruritus were calculated using random-effects or fixed-effects model depending on the heterogeneity of included studies. Results: Of 5,065 studies initially identified, a total of 20,532 patients from 144 studies were included for analysis. The summary incidences of all-grade and high-grade pruritus were 17.4% (95% confidence interval (CI): 16.0%-19.0%) and 1.4% (95% CI: 1.2%-1.6%). From randomized controlled trials, patients treated with targeted therapies had a significantly increased risk of developing all-grade pruritus, with an overall RR of 2.59 (95% CI: 2.03-3.30, p<0.001); there was a significant variation among different classes of drugs (P<0.001). Conclusions: There is a significant risk of developing pruritus in cancer patients receiving targeted therapies. In order to prevent suboptimal dosing and reductions in quality of life, these patients should be counseled and treated against this disabling event.

Tolerability of dual checkpoint blockade with nivolumab and ipilimumab: A meta-analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15149-e15149
Author(s):  
Alejandro Ramon Carvajal ◽  
Judy Huang ◽  
Shenhong Wu
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Cancer Patients ◽  
Fixed Effects ◽  
Risk Mitigation ◽  
Meta Analysis ◽  
Checkpoint Blockade ◽  
Discontinuation Rate ◽  
Fixed Effects Model ◽  
Increased Risk

e15149 Background: The dual checkpoint blockade of PD-1 and CTLA-4 with nivolumab and ipilimumab have been used extensively for cancer immunotherapy in clinical practice and trials due to its efficacy. A critical concern is the tolerability of the combination due to the increased risk of severe immune-mediated adverse events. A meta-analysis of clinical trials was performed to assess the treatment tolerability measured as discontinuation due to adverse events. Methods: A search through PubMed as well as abstracts presented at the American Society of Clinical Oncology (ASCO) conferences until December 2019 was performed to identify clinical trials in which the combination of nivolumab and ipilimumab was given to cancer patients. Eligible clinical trials reported a discontinuation rate due to adverse events for the groups of patients receiving nivolumab and ipilimumab. A random or fixed effects model was used to determine summary incidences, relative risks, and 95% confidence intervals. Results: Seven clinical studies which included a total of 3,213 patients (combo: 1746, control: 1467) with various cancers were selected. Overall, the intolerability of nivolumab and ipilimumab measured as the summary incidence of discontinuation due to adverse events was 25.1% (95% CI: 17.8-34.1%). The rate varied significantly with the type of cancer (P < 0.001). The lowest discontinuation rate was in uveal melanoma, with a rate of 11% (95% CI: 2.9-34.2%), and the highest discontinuation rate was in melanoma at 46.3% (95% CI: 36.6-56.4%). In comparison with chemotherapy controls from randomized controls, the intolerability was significantly higher with an relative risk of 2.1 (95% CI: 1.78-2.84) for the combination. Conclusions: There is a substantial risk for intolerability in cancer patients receiving the combination nivolumab and ipilimumab. Further studies are needed for risk mitigation.

Incidence of pneumonitis among limited-stage small cell lung cancer patients exposed to concurrent chemoradiation: A systematic literature review and meta-analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e20592-e20592
Author(s):  
Ke (Kirsten) Zu ◽  
Yuting Kuang ◽  
Arianna Nevo ◽  
Maria Catherine Pietanza ◽  
Mike Liu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Fixed Effects ◽  
Randomized Trials ◽  
Meta Analysis ◽  
Therapeutic Agents ◽  
Small Cell ◽  
Fixed Effects Model ◽  
Small Cell Lung ◽  
First Line ◽  
Grade 3

e20592 Background: Concurrent chemoradiation (cCRT) has been the standard first line treatment for patients with limited-stage small cell lung cancer (LS-SCLC) for decades. Despite continued progress in refining chemotherapy and radiation modalities, the prognosis for LS-SCLC remains unsatisfactory with cCRT alone. Recent clinical trials have sought to further improve survival by combining cCRT and other newly developed therapeutic agents in treating LS-SCLC. Severe (grade 3 or higher) pneumonitis is one of the major toxicities related to cCRT. The objective of this study was to establish a benchmark rate of pneumonitis in LS-SCLC patients receiving first line cCRT. Methods: A systematic literature review and meta-analysis was performed in accordance with Cochrane, PRISMA, and Food and Drug Administration guidelines to summarize and quantify the incidence of grade 3−5 and fatal pneumonitis (including radiation pneumonitis) in patients with LS-SCLC exposed to cCRT alone. MEDLINE, Embase, and the Cochrane Central Register were searched from 2014 to July 16, 2020 to identify relevant randomized controlled trials (RCTs) and non-RCT studies (observational studies or non-randomized trials). The study quality of included RCTs and non-RCT studies was evaluated using the Revised Cochrane Risk of Bias Tool for Randomized Trials (RoB2) and the Newcastle-Ottawa scale, respectively. The incidence of pneumonitis across studies was pooled using a frequentist method with correction for zero events, using the metafor package in R 3.6.1. Results: Thirteen studies (4 RCTs, 9 non-RCTs) were included in the review. Patient populations were comparable across studies and the median follow-up ranged from 20−59 months. All patients received etoposide with either cisplatin or carboplatin, and radiation doses, given once or twice daily, ranging from 40−72 Gy. While all RCTs were open-label studies that could have some deviations from the intended interventions, this did not impact the reported incidence of pneumonitis. All non-RCTs were of high quality. Ten studies were included in the meta-analysis (3 RCTs, 7 non-RCTs; 1,539 patients). The pooled incidence of grade 3−5 pneumonitis was 3.28% [95% confidence interval (CI): 1.52−5.04%] in RCTs from random-effects model, and 6.34% [95% CI: 3.64−9.04%] in non-RCTs from fixed-effects model. The pooled incidence risk of grade 5 (fatal) pneumonitis was 0.29% [95% CI: 0.00−0.62%] in RCTs and 0.88% [95% CI: 0.02−1.74%] in non-RCTs, both from fixed-effects model. Conclusions: In LS-SCLC patients exposed to cCRT, the incidence of grade 3−5 pneumonitis and fatal pneumonitis ranges from 3.28−6.34% and 0.29−0.88%, respectively. These results can be used to understand the safety of other therapeutic agents with regard to pneumonitis when used in combination with cCRT to treat patients with LS-SCLC.

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