Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study

Goldman, Jonathan W.; Garassino, Marina Chiara; Chen, Yuanbin; Özgüroǧlu, Mustafa; Dvorkin, Mikhail; Trukhin, Dmytro; Statsenko, Galina; Hotta, Katsuyuki; Ji, Jun Ho; Hochmair, Maximilian; Войтко, Олександр; Havel, Libor; Poltoratskiy, A.; Losonczy, György; Reinmuth, Niels; Patel, Nikunj; Laud, Peter J.; Shire, Norah J.; Jiang, Haiyi; Paz‐Ares, Luis

doi:10.1016/j.lungcan.2020.09.003

Cited by 98 publications

(183 citation statements)

References 21 publications

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“…Benefits were consistent across patient subgroups and quality of life (QoL) was maintained. 57 The addition of tremelimumab to durvalumab and the platinum doublet did not show any improvement in outcomes compared with ChT. With very similar results, and in the context of a severe unmet need, both trials justify the need for immunotherapy in the frontline setting.…”

Section: Management Of Extensive-stage Diseasementioning

confidence: 86%

“…A statistically significant improvement in OS was reported with the addition of durvalumab to ChT, with a median OS of 12.9 months (95% CI 11.3-14.7 months) for durvalumab plus ChT versus 10.5 months (95% CI 9.3-11.2 months) for platinum plus etoposide alone (HR 0.75; 95% CI 0.62-0.91; P ¼ 0.0032). 56 OS at 18 months was 32.0% (95% CI 26.5% to 37.7%) for durvalumab versus 24.8% (95% CI 19.7% to 30.1%) in the ChT-only group. Benefits were consistent across patient subgroups and quality of life (QoL) was maintained.…”

Section: Management Of Extensive-stage Diseasementioning

confidence: 94%

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Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆

et al. 2021

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Section: Management Of Extensive-stage Diseasementioning

confidence: 86%

Section: Management Of Extensive-stage Diseasementioning

confidence: 94%

Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆

et al. 2021

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“…Secondary endpoints included PFS and unconfirmed objective response rate based on investigator assessment according to RECIST v1.1, and safety and tolerability. In addition, symptoms and health-related quality of life assessments were a prespecified secondary endpoint and have been reported in the global population [ 20 ]. Confirmed objective response rate and duration of confirmed response were analyzed post hoc.…”

Section: Methodsmentioning

confidence: 99%

First-line durvalumab plus platinum-etoposide in extensive-stage small-cell lung cancer: CASPIAN Japan subgroup analysis

et al. 2021

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Background In the phase 3 CASPIAN study (NCT03043872), first-line durvalumab plus etoposide and cisplatin or carboplatin (EP) significantly improved OS versus EP alone in patients with extensive-stage (ES)-SCLC (HR 0.73 [95% CI 0.59–0.91; p = 0.0047]). Here we report results for a preplanned subgroup analysis of patients recruited in Japan. Methods Treatment-naïve patients with ES-SCLC received either 4 cycles of durvalumab 1500 mg plus EP q3w followed by maintenance durvalumab 1500 mg q4w until disease progression or up to 6 cycles of EP q3w. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), safety, and tolerability. Results In the Japan subgroup, 18 patients were randomized to durvalumab plus EP and 16 patients to EP. At the interim analysis with a median follow-up of 12.5 months in the subgroup, OS numerically favored durvalumab plus EP versus EP (HR 0.77 [95% CI 0.26‒2.26]; median not reached vs 15.2 months). PFS was similar for durvalumab plus EP versus EP (HR 0.90 [95% CI 0.43‒1.89]). Confirmed ORR was 89% with durvalumab plus EP versus 69% with EP. Adverse events (AEs) of CTCAE grade 3 or 4 were reported in 78% versus 94% of patients in the durvalumab plus EP versus EP arms. There were no AEs leading to treatment discontinuation or death in the Japan subgroup. Conclusion First-line durvalumab plus EP was effective and well tolerated in Japanese patients with ES-SCLC. Despite the small size of the Japan subgroup, results were generally consistent with the global study population.

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“…IrAE's were reported in 20% of patients treated with durvalumab, 5% had grade ≥3. Functioning and HRQoL favoured the combination of durvalumab with chemotherapy compared to chemotherapy alone (52). Durvalumab in combination with chemotherapy is recently approved as a first line treatment for ED-SCLC by the FDA (53).…”

Section: First Line Sclc Extensive Diseasementioning

confidence: 99%

Immunotherapy in small cell lung cancer: one step at a time: a narrative review

Dumoulin¹,

Dingemans²,

Aerts³

et al. 2021

Transl Lung Cancer Res

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Chemotherapy with or without radiotherapy has been the standard of care for many years for patients with small cell lung cancer (SCLC). Despite exceptionally high responses (up to 80%) with chemotherapy, the majority of patients relapse rapidly within weeks to months after treatment completion.Therefore, new and better treatment options are necessary. Recently, synergistic activity has been reported for the addition of immune checkpoint inhibitors (ICI) to standard platinum-based chemotherapy in the therapeutic strategy of advanced SCLC. For the first time after several decades, a significant survival improvement was achieved for this population. However, the overwhelming majority of patients do not respond to ICI, or relapse rapidly. There is need for better knowledge about the biology, histopathologic features, and molecular pathways of SCLC. This can probably help to identify the optimal predictive biomarkers, which are warranted to develop an individual therapeutic strategy including the rational use of a combination of immunotherapeutic agents. Here, we provide an overview of the rationale for and clinical results of the completed and ongoing trials using different strategies of immunotherapy in SCLC.In addition, opportunities for further improvement of therapies will be discussed, including the addition of radiotherapy, co-stimulatory antibodies, and other immune modifying agents.

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Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study

Cited by 98 publications

References 21 publications

Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆

Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆

First-line durvalumab plus platinum-etoposide in extensive-stage small-cell lung cancer: CASPIAN Japan subgroup analysis

Immunotherapy in small cell lung cancer: one step at a time: a narrative review

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