Randomized phase III trial of amrubicin versus topotecan (Topo) as second-line treatment for small cell lung cancer (SCLC).

Jotte, Robert M.; Pawel, Joachim von; Spigel, David R.; Socinski, Mark A.; O'Brien, M.; Paschold, Eugene; Mezger, J.; Steins, Martin; Bosquee, Léon; Bubis, Jeffrey A.; Nackaerts, K.; Pérez, Jimena; Clingan, P.; Schuette, Wolfgang; Lorigan, Paul; Reck, Martin; Dómine, Manuel; Shepherd, Frances A.; McNally, R.; Renschler, Markus F.

doi:10.1200/jco.2011.29.15_suppl.7000

Cited by 32 publications

(24 citation statements)

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“…At this point, the approval of amrubicin for the treatment of any cancer in the US appears unlikely. Although amrubicin is approved for the treatment of small cell and nonsmall cell lung cancer in Japan, a US phase 3 trial in relapsed small cell lung cancer failed to duplicate the results of the randomized phase 2 trials, and showed no survival benefit versus topotecan [16].…”

Section: Discussionmentioning

confidence: 94%

Amrubicin as second- or third-line treatment for women with metastatic HER2-negative breast cancer: a Sarah Cannon Research Institute phase 1/2 trial

Yardley¹,

Raefsky²,

Hainsworth³

et al. 2014

Breast Cancer Res Treat

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Amrubicin is a synthetic anthracycline which has been shown in preclinical studies to have broad-spectrum anti-tumor activity and a lower potential for cardiotoxicity as compared to doxorubicin. We conducted a phase 1/2 trial of single-agent amrubicin as second- or third-line treatment for women with metastatic breast cancer. Women with metastatic HER2-negative breast cancer who had normal cardiac function and measurable disease, received intravenous (IV) amrubicin every 3 weeks. Prophylactic treatment with granulocyte colony-stimulating factors (G-CSFs) was recommended. Escalating amrubicin doses were administered in a 3 + 3 design in the phase 1 portion to determine the maximum tolerated dose. Achievement of a median PFS ≥4.5 months would warrant further development of amrubicin in this setting. Seventy-eight women (median age 58 years) were treated (phase 1, 15 patients; phase 2, 63 patients). An amrubicin dose of 110 mg/m(2) every 3 weeks was selected as the phase 2 dose, and 66 patients were treated. Twelve of 66 patients (18%) achieved objective response, and the clinical benefit rate was 42%. Median PFS was 4 months (95% CI 2.5, 5.8). Neutropenia was the most common grade 3/4 toxicity, observed in 29 patients (44%). One patient experienced an asymptomatic transient left ventricular ejection fraction decline (grade 3). Although the study did not meet the predefined PFS, amrubicin was well tolerated at 110 mg/m(2) IV when administered every 3 weeks with prophylactic G-CSF, and was an active second- or third-line treatment for metastatic HER2-negative breast cancer.

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Section: Discussionmentioning

confidence: 94%

Amrubicin as second- or third-line treatment for women with metastatic HER2-negative breast cancer: a Sarah Cannon Research Institute phase 1/2 trial

Yardley¹,

Raefsky²,

Hainsworth³

et al. 2014

Breast Cancer Res Treat

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“…There are phase II data in both second-line [37,38] and first-line in Caucasian patients with extensive disease [74]. One randomised trial in second-line therapy, which compared amrubicin to topotecan, has been presented in abstract form [75] and appears to suggest activity in Caucasian patients.…”

Section: Newer Chemotherapeutic Agentsmentioning

confidence: 99%

Update on small cell lung cancer management

Huber¹,

Tufman²

2012

breathe

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SummarySmall cell lung cancers (SCLCs) account for ,15-20% of all lung cancers. Because SCLC is almost always associated with long-term tobacco smoking, abstinence from smoking and smoking cessation are crucial for primary prevention. Because symptoms are generally unspecific, the disease is often diagnosed late, with 70% of patients already in stage IIIb or IV at the time of diagnosis. Early detection of SCLC through screening is under investigation. Chemotherapy, generally a platinum-based combination, is the mainstay of therapy and is generally combined with radiation in the first-line treatment of tumours up to stage IIIb. Surgery has a place in the diagnosis and therapy of stage I SCLC, but plays no key role in advanced cancer. In patients who respond to first-line therapy, prophylactic cranial irradiation can prevent brain metastases and improve overall survival. Although the initial response to treatment is usually good, SCLC tends to relapse quickly. This makes second-line therapy quite important. Topotecan is the most studied and widely used agent in second-line therapy; however, newer agents, including biological therapies, are under study. Statement of interestNone declared.HERMES syllabus links: module B. 2. 1

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“…Les résultats d'une phase III dont l'objectif principal était la survie globale, avec une nouvelle anthracycline, l'amrubicine, n'ont pas montré de supériorité sur le topotécan [15]. Cette étude comprenait 637 patients dont 342 étaient « sensibles » (ITL > 90 jours), les taux de réponse étaient en faveur de l'amrubicine 31 % contre 17 % pour le topotécan, la survie sans progression et la survie médiane étaient similaires dans chaque bras (4,1 versus 4,0 mois, 7,5 versus 7,8 mois respectivement).…”

Section: Dossierunclassified

“…Cette pratique repose sur des études anciennes pour lesquelles l'effectif de patients inclus était faible. Postmus et al ont rapporté des taux de réponse chez 62 % des patients avec la reprise du traitement initial par CDE lorsque l'intervalle de temps sans traitement était supé-rieur à six mois après une réponse initiale [15]. Il n'y a cependant pas d'étude randomisée dans la littéra-ture qui compare le topotécan à la réintroduction d'un sel de platine associé à l'étoposide.…”

Section: Dossierunclassified

Treatment of metastatic small-cell lung cancer in 2012

Baize

2012

Oncologie

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Randomized phase III trial of amrubicin versus topotecan (Topo) as second-line treatment for small cell lung cancer (SCLC).

Cited by 32 publications

References 0 publications

Amrubicin as second- or third-line treatment for women with metastatic HER2-negative breast cancer: a Sarah Cannon Research Institute phase 1/2 trial

Amrubicin as second- or third-line treatment for women with metastatic HER2-negative breast cancer: a Sarah Cannon Research Institute phase 1/2 trial

Update on small cell lung cancer management

Treatment of metastatic small-cell lung cancer in 2012

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