Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 trial

Bisogno, Gianni; Salvo, Gian Luca De; Bergeron, Christophe; Gallego, Soledad; Merks, Johannes H. M.; Kelsey, Anna; Martelli, Hélène; Minard‐Colin, Véronique; Orbach, Daniel; Glosli, Heidi; Chisholm, Julia; Casanova, Michela; Zanetti, Ilaria; Devalck, Christine; Ben-Arush, Myriam; Múdrý, Peter; Ferman, Sima; Jenney, Meriel; Ferrari, Andrea

doi:10.1016/s1470-2045(19)30617-5

Cited by 175 publications

(201 citation statements)

References 28 publications

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“…1,3,5,17,18 The local therapy approach differed per protocol. Treatment generally consisted of a combination of chemotherapy with surgery and/or radiotherapy, as described previously.…”

Section: Methodsmentioning

confidence: 99%

Is surveillance imaging in pediatric patients treated for localized rhabdomyosarcoma useful? The European experience

Vaarwerk

Mallebranche

Affinita

et al. 2019

Cancer

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BACKGROUND: After the completion of therapy, patients with localized rhabdomyosarcoma (RMS) are subjected to intensive radiological tumor surveillance. However, the clinical benefit of this surveillance is unclear. This study retrospectively analyzed the value of off-therapy surveillance by comparing the survival of patients in whom relapse was detected by routine imaging (the imaging group) and patients in whom relapse was first suspected by symptoms (the symptom group). METHODS: This study included patients with relapsed RMS after the completion of therapy for localized RMS who were treated in large pediatric oncology hospitals in France, the United Kingdom, Italy, and the Netherlands and who were enrolled in the International Society of Paediatric Oncology Malignant Mesenchymal Tumor 95 (1995)(1996)(1997)(1998)(1999)(2000)(2001)(2002)(2003)(2004) study, the Italian Paediatric Soft Tissue Sarcoma Committee Rhabdomyosarcoma 96 (1996-2004) study, or the European Paediatric Soft Tissue Sarcoma Study Group Rhabdomyosarcoma 2005 (2005-2013) study. The survival times after relapse were compared with a log-rank test between patients in the imaging group and patients in the symptom group. RESULTS: In total, 199 patients with relapsed RMS were included: 78 patients (39.2%) in the imaging group and 121 patients (60.8%) in the symptom group. The median follow-up time after relapse was 7.4 years (interquartile range, 3.9-11.5 years) for survivors (n = 86); the 3-year postrelapse survival rate was 50% (95% confidence interval [CI], 38%-61%) for the imaging group and 46% (95% CI, 37%-55%) for the symptom group (P = .7). CONCLUSIONS: Although systematic routine imaging is the standard of care after RMS therapy, the majority of relapses were detected as a result of clinical symptoms. This study found no survival advantage for patients whose relapse was detected before the emergence of clinical symptoms. These results show that the value of off-therapy surveillance is controversial, particularly because repeated imaging may also entail potential harm. Cancer 2020;126:823-831.

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“…1,3,5,17,18 The local therapy approach differed per protocol. Treatment generally consisted of a combination of chemotherapy with surgery and/or radiotherapy, as described previously.…”

Section: Methodsmentioning

confidence: 99%

Is surveillance imaging in pediatric patients treated for localized rhabdomyosarcoma useful? The European experience

Vaarwerk

Mallebranche

Affinita

et al. 2019

Cancer

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“…Despite improving EFS, our analysis did not identify a significant association of early tumor response with OS, a theme observed in other solid tumors that highlights the limits of conventional cytotoxic chemotherapy regimens . Further augmentation of therapy for metastatic Ewing sarcoma must be investigated via incorporation of novel targeted or biological agents, or the addition of low‐dose metronomic maintenance therapy as successfully implemented recently for rhabdomyosarcoma …”

Section: Discussionmentioning

confidence: 82%

“…23 Further augmentation of therapy for metastatic Ewing sarcoma must be investigated via incorporation of novel targeted or biological agents, 24 or the addition of low-dose metronomic maintenance therapy as successfully implemented recently for rhabdomyosarcoma. 25 A unique aspect of our cohort is the selective administration of WLI, a practice based on early reports of survival in Ewing sarcoma patients treated at our institution who cleared pulmonary lesions and did not receive WLI. 15 Administration of WLI has been considered standard among most pediatric oncology centers, after early reports from Memorial Sloan Kettering and group collaborative studies suggested benefit to its broad implementation.…”

Section: Discussionmentioning

confidence: 99%

Clinical impact of post‐induction resolution of pulmonary lesions in metastatic Ewing sarcoma

Halalsheh

Kaste

Krasin

et al. 2020

Pediatric Blood & Cancer

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Background Patients with metastatic Ewing sarcoma experience poor outcomes despite intensive systemic and local therapy. Early chemotherapy response of pulmonary metastases has been associated with prognosis in other pediatric malignancies. We reviewed the outcomes of patients with Ewing sarcoma and pulmonary metastases treated at our institution based on therapy received and early pulmonary response. Materials and methods We retrospectively reviewed patients with newly diagnosed Ewing sarcoma and pulmonary metastases at St. Jude Children's Research Hospital between 1979 and 2015. Data obtained included demographic and treatment characteristics including chemotherapy, local control measures, whole lung irradiation (WLI) administration, autologous stem cell transplantation, and outcomes. Patients were evaluated for radiographic post‐induction pulmonary complete response (CR). We estimated event‐free survival (EFS) and overall survival (OS) and used Cox proportional hazards regression to examine the effects of clinical and treatment factors on outcomes. Results Fifty‐four patients (median age, 12.9 years) were evaluated. Post‐induction pulmonary CR was observed in 33 (61%) patients. WLI was delivered to 16 patients (4/33 with pulmonary CR and 12/21 with non‐CR). At median 3.6 years follow‐up, five‐year EFS and OS were 30.8% ± 6.4% and 49.6% ± 7.1%, respectively. Post‐induction pulmonary CR was associated with prolonged EFS (P < 0.001) but not improved OS (P = 0.065). Post‐induction pulmonary CR was associated with a lower incidence of lung failure (P = 0.031). Conclusions Post‐induction pulmonary CR is associated with improved EFS in patients with Ewing sarcoma who present with pulmonary metastases.

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“…The interest in a possible role of longer chemotherapy duration has been renewed by the results recently obtained in the EpSSG RMS2005 trial. This trial demonstrated that the addition of low‐intensity maintenance chemotherapy to the standard chemotherapy increases patients’ survival . Different explanations for this result have been advanced including the fact that patients receiving maintenance had the chemotherapy prolonged by 24 weeks.…”

Section: Discussionmentioning

confidence: 95%

“…OS was improved for patients receiving maintenance compared to those who discontinued therapy after 27 weeks of intensive chemotherapy. 29 An exploratory analysis, taking into account prognostic factorssuch as age at diagnosis, histological subtype or fusion status, nodal involvement, tumor size and site, and IRS group-was not able to reveal a significant benefit of maintenance in any specific subgroup of patients.…”

Section: The European Pediatric Soft Tissue Sarcoma Study Groupmentioning

confidence: 94%

An unresolved issue in rhabdomyosarcoma treatment: The duration of chemotherapy

Bisogno

Hawkins

2020

Pediatric Blood & Cancer

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Clinical trials have tested different chemotherapy regimens to improve outcome for patients with rhabdomyosarcoma (RMS), but therapy duration has never been explicitly evaluated. North American trials evolved from longer (104 weeks) to shorter duration (24‐42 weeks). In Europe, treatment duration similarly evolved from 35 to 48 to 22 weeks for lower risk patients and from 56 to 72 to 27 weeks for higher risk patients. There was no evidence that chemotherapy duration influenced outcome over time. The recent RMS2005 trial showed an improved survival with the addition of 24 weeks of low‐dose chemotherapy. Treatment duration remains a question to be addressed in future trials.

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Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 trial

Cited by 175 publications

References 28 publications

Is surveillance imaging in pediatric patients treated for localized rhabdomyosarcoma useful? The European experience

Is surveillance imaging in pediatric patients treated for localized rhabdomyosarcoma useful? The European experience

Clinical impact of post‐induction resolution of pulmonary lesions in metastatic Ewing sarcoma

An unresolved issue in rhabdomyosarcoma treatment: The duration of chemotherapy

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