Comparison of carboplatin plus etoposide with amrubicin monotherapy for extensive‐disease small cell lung cancer in the elderly and patients with poor performance status

Igawa, Satoshi; Shirasawa, Masayuki; Ozawa, Tetsuya; Nishinarita, Noriko; Okuma, Yuriko; Ono, Taihei; Sugimoto, Ai; Kurahayashi, Shintaro; Sugita, Keisuke; Sone, Hideyuki; Fukui, Tomoya; Mitsufuji, Hisashi; Kubota, Minoru; Katagiri, Masayuki; Sasaki, Jiichiro; Naoki, Katsuhiko

doi:10.1111/1759-7714.12772

Cited by 11 publications

(12 citation statements)

References 30 publications

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“…In our previous retrospective cohort study, elderly patients with SCLC who received CE achieved a significantly longer PFS than those receiving AMR in the first‐line treatment, accordingly indicating that CE is an effective standard chemotherapeutic for chemo‐naïve elderly patients with ED‐SCLC. Given the few available regimens for second‐line chemotherapy for ED‐SCLC patients, it is reasonable to conclude that AMR is inevitably essential for elderly patients with relapsed ED‐SCLC.…”

Section: Discussionmentioning

confidence: 87%

“…Therefore, we selected 40 mg/m 2 AMR as a starting dose for elderly patients with relapsed SCLC. In addition, data from previous literature and a phase III study showed no significant differences in OS and objective response rate between CE and AMR, indicating that CE is more suitable as a first‐line chemotherapy …”

Section: Discussionmentioning

confidence: 90%

“…In addition, data from previous literature and a phase III study 24 showed no significant differences in OS and objective response rate between CE and AMR, indicating that CE is more suitable as a first-line chemotherapy. 19,25,26 Imai et al showed that AMR was effective and safe for elderly patients with relapsed ED-SCLC, reporting PFS of 3.4 months and OS of 6.1. 27 In their study, the PFS and OS in the refractory cases were 2.7 and 5.5 months, respectively.…”

Section: Discussionmentioning

confidence: 99%

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Amrubicin monotherapy for elderly patients with relapsed extensive‐disease small‐cell lung cancer: A retrospective study

et al. 2018

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BackgroundPrevious studies have shown amrubicin (AMR) to be an effective second‐line treatment option for small‐cell lung cancer (SCLC). However, the efficacy of AMR in elderly patients with relapsed SCLC has not been sufficiently evaluated.MethodsThe medical records of elderly patients with relapsed SCLC who received AMR as second‐line chemotherapy were retrospectively reviewed, and their treatment outcomes were evaluated.ResultsThirty‐one patients with a median age of 72 years (22 patients with sensitive relapse and 9 with refractory relapse) were analyzed. The median number of treatment cycles was four (range: 1–10), and the response rate was 29%. The median progression‐free survival (PFS) and overall survival (OS) were 5.4 and 11.6 months, respectively. The OS of 22 patients who received third‐line chemotherapy was 15.5 months. The PFS (6.2 vs. 3.2 months; P = 0.002) and OS (14.8 vs. 5.7 months; P = 0.004) were significantly longer in patients with sensitive relapse than those with refractory relapse. The frequency of grade 3 or higher neutropenia was high (n = 18, 58%), while febrile neutropenia was only observed in five patients (16%). Non‐hematological toxic effects were relatively mild, and pneumonitis and treatment‐related deaths were not observed.ConclusionAMR may be a feasible and effective regimen for elderly patients with relapsed SCLC.

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Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 99%

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Amrubicin monotherapy for elderly patients with relapsed extensive‐disease small‐cell lung cancer: A retrospective study

et al. 2018

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“…Fixed-effect model was used if the assessment of heterogeneity was insignificant (I 2 ≤50%). If the source of heterogeneity was not insignificant (I 2 ＞50%) uncertain, we used the random-effect model for further analysis 15. A P -value less than 0.05 was identified as statistically significant difference.…”

Section: Methodsmentioning

confidence: 99%

<p>The safety and efficacy of amrubicin in the treatment of previously untreated extensive-disease small-cell lung cancer: a meta-analysis</p>

Zhou

et al. 2019

OTT

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Background: Extensive-disease small-cell lung cancer (ED-SCLC) has been known to be rapid progression and relapse, despite highly sensitive to chemotherapy. Amrubicin (AMR), a third-generation synthetic anthracycline, was accepted as a feasible alternative compared with the standard first-line chemotherapy for previously untreated ED-SCLC. While, the efficacies of these amrubicin-based regimens are unsatisfactory. Aim: Our meta-analysis was performed to assess the efficacy and toxicity of first-line therapy comparing AMR and chemotherapy in patients with ED-SCLC. Methods: Electronic databases were searched for eligible trials updated on November 2018. Randomized-controlled trials assessing the efficacy and safety of AMR in ED-SCLC were included, of which the interested results were objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs). Results: A total of 6 randomized controlled trials were included in this analysis. There are no significant differences in OS (OR=1.03, 95% CI=0.66–1.60, P =0.91), PFS (OR=1.2, 95% CI=10.77–1.88, P =0.41) or ORR (OR=1.31, 95% CI=0.90–1.92, P =0.16) with AMR (OR=0.90, 95% CI=0.76–1.05, P =0.17). The most common treatment-related AEs in the AMR group are leukopenia (OR=3.13, 95% CI=1.22–7.99, P =0.02) and neutropenia (OR=3.25, 95% CI=1.38–7.65, P =0.007). Fatigue, anemia, nausea, vomiting, diarrhea the difference between the two groups had no statistical significance. Conclusion: The results of our analysis indicated that AMR therapy demonstrated non-inferiority to the standard first-line chemotherapy for previously untreated ED-SCLC. Whether it can be accepted as an alternative regimen to the standard first-line chemotherapy is still warranted.

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“…It is capable of interfering with mammalian DNA topoisomerase II in the late S or G2 phase of the cell cycle, and combines with enzymes and DNA to fabricate a drug-enzyme-DNA stable reversible complex, which can irreparably impair DNA, eventually causing apoptosis. 1 , 2 For its prominent anti-tumor effect, it has been applied for treating various tumors, such as leukemia, lymphoma, small cell lung cancer and oropharyngeal cancer. 3 , 4 However, as a BCS IV drug, etoposide exhibits insufficient aqueous solubility and permeability, 5 , 6 resulting in many formulations of etoposide being prepared as injections.…”

Section: Introductionmentioning

confidence: 99%

<p>Etoposide Amorphous Nanopowder for Improved Oral Bioavailability: Formulation Development, Optimization, in vitro and in vivo Evaluation</p>

Wang

et al. 2020

IJN

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Introduction: Etoposide refers to a derivative of podophyllotoxin, which plays an important role in the treatment of cancer due to its prominent anti-tumor effect. As a BCS IV drug, etoposide exhibits insufficient aqueous solubility and permeability, thereby limiting its oral absorption. To enhance the oral bioavailability of etoposide, this study developed an amorphous nanopowder. Methods: Based on preliminary screening and experimental design, the stabilizer and preparation process of etoposide nanosuspension were explored. Subsequently, using a Box-Behnken design, the effects of independent factors (ultrasonication time, ratio of two phases and stabilizer concentration) on response variables (particle size and polydispersity index) were studied, and then the formulation was optimized. Finally, nanosuspension was further freeze dried with 1% of mannitol resulting in the formation of etoposide amorphous nanopowder. Results: The optimized etoposide nanopowder showed as spherical particles with an average particle size and polydispersity index of 211.7 ± 10.4 nm and 0.125 ± 0.028. X-ray powder diffraction and differential scanning calorimetry confirmed the ETO in the nanopowder was amorphous. Compared with coarse powder and physical mixture, etoposide nanopowder achieved significantly enhanced saturated solubility and dissolution in various pH environments. The C max and AUC 0-t of etoposide nanopowder after oral administration in rats were respectively 2.21 and 2.13 times higher than the crude etoposide suspension. Additionally, the T max value of nanopowder was 0.25 h, compared with 0.5 h of reference group. Discussion: In the present study, the optimized amorphous nanopowder could significantly facilitate the dissolution and oral absorption of etoposide and might act as an effective delivery method to enhance its oral bioavailability.

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Comparison of carboplatin plus etoposide with amrubicin monotherapy for extensive‐disease small cell lung cancer in the elderly and patients with poor performance status

Cited by 11 publications

References 30 publications

Amrubicin monotherapy for elderly patients with relapsed extensive‐disease small‐cell lung cancer: A retrospective study

Amrubicin monotherapy for elderly patients with relapsed extensive‐disease small‐cell lung cancer: A retrospective study

<p>The safety and efficacy of amrubicin in the treatment of previously untreated extensive-disease small-cell lung cancer: a meta-analysis</p>

<p>Etoposide Amorphous Nanopowder for Improved Oral Bioavailability: Formulation Development, Optimization, in vitro and in vivo Evaluation</p>

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