Maintenance Chemotherapy

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Heidi Glosli - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Lancet Oncology, 2019
    Co-Authors: Gianni Bisogno, Soledad Gallego Melcon, Johannes H. M. Merks, Anna Kelsey, Véronique Minard-colin, Gian Luca De Salvo, Helene Martelli, Daniel Orbach, Christophe Bergeron, Heidi Glosli
    Abstract:

    Summary Background For more than three decades, standard treatment for rhabdomyosarcoma in Europe has included 6 months of Chemotherapy. The European paediatric Soft tissue sarcoma Study Group (EpSSG) aimed to investigate whether prolonging treatment with Maintenance Chemotherapy would improve survival in patients with high-risk rhabdomyosarcoma. Methods RMS 2005 was a multicentre, open-label, randomised, controlled, phase 3 trial done at 102 hospitals in 14 countries. We included patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement. Patients in remission after standard treatment (nine cycles of ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue Maintenance Chemotherapy (six cycles of intravenous vinorelbine 25 mg/m2 on days 1, 8, and 15, and daily oral cyclophosphamide 25 mg/m2, on days 1–28). Randomisation was done by use of a web-based system and was stratified (block size of four) by enrolling country and risk subgroup. Neither investigators nor patients were masked to treatment allocation. The primary outcome was disease-free survival in the intention-to-treat population. Secondary outcomes were overall survival and toxicity. This trial is registered with EudraCT, number 2005-000217-35, and ClinicalTrials.gov , number NCT00339118 , and follow-up is ongoing. Findings Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive Maintenance Chemotherapy. Median follow-up was 60·3 months (IQR 32·4–89·4). In the intention-to-treat population, 5-year disease-free survival was 77·6% (95% CI 70·6–83·2) with Maintenance Chemotherapy versus 69·8% (62·2–76·2) without Maintenance Chemotherapy (hazard ratio [HR] 0·68 [95% CI 0·45–1·02]; p=0·061), and 5-year overall survival was 86·5% (95% CI 80·2–90·9) with Maintenance Chemotherapy versus 73·7% (65·8–80·1) without (HR 0·52 [95% CI 0·32–0·86]; p=0·0097). Toxicity was manageable in patients who received Maintenance Chemotherapy: 136 (75%) of 181 patients had grade 3–4 leucopenia, 148 (82%) had grade 3–4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection. One (1%) patient had a grade 4 non-haematological toxicity (neurotoxicity). Two treatment-related serious adverse events occurred: one case of inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved. Interpretation Adding Maintenance Chemotherapy seems to improve survival for patients with high-risk rhabdomyosarcoma. This approach will be the new standard of care for patients with high-risk rhabdomyosarcoma in future EpSSG trials. Funding Fondazione Citta della Speranza, Association Leon Berard Enfant Cancereux, Clinical Research Hospital Program (French Ministry of Health), and Cancer Research UK.

Michiaki Mishima - One of the best experts on this subject based on the ideXlab platform.

  • Long survival of a small-cell lung cancer patient who received Maintenance Chemotherapy with irinotecan.
    Case reports in oncology, 2013
    Co-Authors: Yoshitaka Yagi, Young Hak Kim, Noriyuki Tajima, Kiichiro Baba, Kensaku Aihara, Hong Hyun Soo, Shinpachi Yamaoka, Michiaki Mishima
    Abstract:

    Lung cancer is the leading cause of cancer-related death worldwide. Small-cell lung cancer (SCLC) accounts for approximately 15% of all lung cancers. It is characterized by rapid tumor growth and early metastasis to multiple organs. Response to initial Chemotherapy is generally good; however, the majority of patients develop recurrence and the prognosis of such patients is reportedly 2-4 months. Evolution of the treatment for SCLC has stagnated, and cisplatin + etoposide has been the standard Chemotherapy for decades. Meanwhile, the combination of cisplatin + irinotecan has demonstrated equivalent efficacy to cisplatin + etoposide. Recently, Maintenance Chemotherapy has been extensively investigated in non-small-cell lung cancer (NSCLC), and is currently recommended as a standard treatment in clinical guidelines. On the contrary, a Maintenance strategy has not been established for SCLC. Here, we describe an SCLC patient who received Maintenance Chemotherapy with irinotecan for more than 2 years after induction Chemotherapy with cisplatin + irinotecan, and survived long term with no recurrence.

  • Maintenance Chemotherapy for non-small-cell lung cancer.
    Cancer treatment reviews, 2011
    Co-Authors: Young Hak Kim, Michiaki Mishima
    Abstract:

    Currently, platinum-based combination Chemotherapy is the standard first-line Chemotherapy for non-small-cell lung cancer (NSCLC). Historically, platinum-based Chemotherapy has been recommended for up to six cycles even for responders, and second-line Chemotherapy has been considered when disease progression is confirmed. In spite of extensive investigations into Maintenance Chemotherapy, no positive data have been obtained; however, the results of recent clinical trials suggest both the safety and efficacy of Maintenance Chemotherapy in patients with NSCLC, although it is still controversial. In this review, we summarize the major clinical trials of Maintenance Chemotherapy in patients with NSCLC, and discuss its clinical validity and present future perspectives.

Gianni Bisogno - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Lancet Oncology, 2019
    Co-Authors: Gianni Bisogno, Soledad Gallego Melcon, Johannes H. M. Merks, Anna Kelsey, Véronique Minard-colin, Gian Luca De Salvo, Helene Martelli, Daniel Orbach, Christophe Bergeron, Heidi Glosli
    Abstract:

    Summary Background For more than three decades, standard treatment for rhabdomyosarcoma in Europe has included 6 months of Chemotherapy. The European paediatric Soft tissue sarcoma Study Group (EpSSG) aimed to investigate whether prolonging treatment with Maintenance Chemotherapy would improve survival in patients with high-risk rhabdomyosarcoma. Methods RMS 2005 was a multicentre, open-label, randomised, controlled, phase 3 trial done at 102 hospitals in 14 countries. We included patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement. Patients in remission after standard treatment (nine cycles of ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue Maintenance Chemotherapy (six cycles of intravenous vinorelbine 25 mg/m2 on days 1, 8, and 15, and daily oral cyclophosphamide 25 mg/m2, on days 1–28). Randomisation was done by use of a web-based system and was stratified (block size of four) by enrolling country and risk subgroup. Neither investigators nor patients were masked to treatment allocation. The primary outcome was disease-free survival in the intention-to-treat population. Secondary outcomes were overall survival and toxicity. This trial is registered with EudraCT, number 2005-000217-35, and ClinicalTrials.gov , number NCT00339118 , and follow-up is ongoing. Findings Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive Maintenance Chemotherapy. Median follow-up was 60·3 months (IQR 32·4–89·4). In the intention-to-treat population, 5-year disease-free survival was 77·6% (95% CI 70·6–83·2) with Maintenance Chemotherapy versus 69·8% (62·2–76·2) without Maintenance Chemotherapy (hazard ratio [HR] 0·68 [95% CI 0·45–1·02]; p=0·061), and 5-year overall survival was 86·5% (95% CI 80·2–90·9) with Maintenance Chemotherapy versus 73·7% (65·8–80·1) without (HR 0·52 [95% CI 0·32–0·86]; p=0·0097). Toxicity was manageable in patients who received Maintenance Chemotherapy: 136 (75%) of 181 patients had grade 3–4 leucopenia, 148 (82%) had grade 3–4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection. One (1%) patient had a grade 4 non-haematological toxicity (neurotoxicity). Two treatment-related serious adverse events occurred: one case of inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved. Interpretation Adding Maintenance Chemotherapy seems to improve survival for patients with high-risk rhabdomyosarcoma. This approach will be the new standard of care for patients with high-risk rhabdomyosarcoma in future EpSSG trials. Funding Fondazione Citta della Speranza, Association Leon Berard Enfant Cancereux, Clinical Research Hospital Program (French Ministry of Health), and Cancer Research UK.

Jia Jin - One of the best experts on this subject based on the ideXlab platform.

  • Maintenance Chemotherapy is effective in patients with metastatic triple negative breast cancer after first line platinum based Chemotherapy
    Annals of palliative medicine, 2020
    Co-Authors: Yang Chen, Jian Zhang, Biyun Wang, Zhonghua Wang, Leiping Wang, Jun Cao, Zhonghua Tao, Yannan Zhao, Chengcheng Gong, Jia Jin
    Abstract:

    BACKGROUND Platinum-based Chemotherapy (PBCT) has gained an important position as a first-line treatment for metastatic triple-negative breast cancer (mTNBC). We assessed whether Maintenance Chemotherapy Maintenance was superior to observation after first-line PBCT in patients with mTNBC. METHODS A total of 265 patients with mTNBC who had exhibited non-PD after 4-6 cycles of firstline PBCT at the Fudan University Shanghai Cancer Center from January 2008 to April 2019 were retrospectively analyzed. 107 patients who did not receive additional treatment were defined as the control observation group, and the remaining 158 patients who continued to receive Maintenance therapy were defined as the Maintenance treatment group. RESULTS The median progression-free survival (PFS) time in the Maintenance group was 9.63 months, which was significantly longer than the PFS time of 7.47 months in the observation group (HR 0.49, 95% CI: 0.37-0.67, P<0.0001). The median overall survival (OS) of the observation group and the Maintenance group was 25.37 months and 31.27 months, respectively (HR 0.65, 95% CI: 0.44-0.95, P=0.019). The survival benefit was still present after adjusting baseline characteristics. Moreover, multivariate analyses suggested that Maintenance Chemotherapy is an independent predictive factor for both PFS and OS. Interaction and stratified analyses showed no difference in the PFS with between the single-drug Maintenance strategy, single agent or doublet group and the doublet-drug Maintenance group. The most common adverse event in this study was hematologic toxicity. Except for hand-foot syndrome (0 vs. 7.6%, P=0.004), the incidence of other adverse events was not significantly different between the observation and Maintenance groups. CONCLUSIONS After achieving non-PD with the first-line PBCT in mTNBC patients, Chemotherapy Maintenance may provide OS benefit prior to the era of biologicals.

Yuancheng Chen - One of the best experts on this subject based on the ideXlab platform.

  • Maintenance Chemotherapy is effective in patients with metastatic triple negative breast cancer after first-line platinum-based Chemotherapy
    Annals of Oncology, 2019
    Co-Authors: Ju-bo Zhang, Yuancheng Chen
    Abstract:

    Abstract Background Platinum-based Chemotherapy (PBCT) has gained an important position as a first-line treatment for metastatic triple-negative breast cancer (mTNBC). We assessed whether Maintenance Chemotherapy is superior to observation after first-line PBCT in patients with mTNB. Methods A total of 265 patients with mTNBC who exhibited disease control after 4-6 cycles of first-line PBCT at the Fudan University Shanghai Cancer Center from January 2008 to November 2016 were retrospectively analyzed. 107 patients who continued without additional treatment were defined as the control observation group, and the remaining 158 patients who continued to receive Maintenance therapy were defined as the Maintenance treatment group. Results The median progression-free survival (PFS) time in the Maintenance group was 9.63 months, which was significantly longer than the PFS time of 7.47 months in the observation group (HR 0.49, 95% CI 0.37-0.67, P  Conclusions After achieving disease control with first-line PBCT in mTNBC patients, single-drug Maintenance Chemotherapy is recommended. Legal entity responsible for the study Fudan University Shanghai Cancer Center. Funding Shanghai Municipal Science and Technology Commission Guidance Project, China (contract no. 18411967800); Shanghai Municipal Commission of Health and Family Planning (grant no. 201640069); Shanghai Natural Science Foundation (grant no. 17ZR1405700); and research grant from Shanghai Hospital Development Center (grant no. SHDC12018X03). Disclosure All authors have declared no conflicts of interest.