Creation of an Integrated Clinical Trial Database and Data Sharing for Conducting New Research by the Japan Lung Cancer Society

Ozawa, Yuichi; Yamamoto, Nobuyuki; Yamamoto, Keiji; Ito, Kentaro; Kenmotsu, Hirotsugu; Hayashi, Hidetoshi; Shukuya, Takehito; Fujimoto, Daichi; Sugawara, Shunichi; Niho, Seiji; Ohe, Yuichiro; Okamoto, Hiroaki; Nakagawa, Kazuhiko; Kiura, Katsuyuki; Yoshino, Ichiro; Gemma, Akihiko

doi:10.1016/j.jtocrr.2022.100317

Cited by 2 publications

(2 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…70-3070-Eb) BACKGROUND Due to improvements in multimodality treatment of non-small-cell lung cancer (NSCLC) there are more patients to experience long-term survival (LTS) even in locally advanced stage III disease [1][2][3][4][5]. Typically, the basis of multimodality treatment is a combination of cisplatin-based induction/concurrent chemotherapy, chemoradiation and/or surgery [1][2][3][4][5]. Consequently, it is becoming more important to follow-up long-term-surviving patients regarding late-toxicities of aggressive multimodality treatment including organ toxicities as well as quality-of-life issues (QoL) [6].…”

mentioning

confidence: 99%

“…Financial Support German Cancer Aid (full grant Registry No. 70-3070-Eb) BACKGROUND Due to improvements in multimodality treatment of non-small-cell lung cancer (NSCLC) there are more patients to experience long-term survival (LTS) even in locally advanced stage III disease [1][2][3][4][5]. Typically, the basis of multimodality treatment is a combination of cisplatin-based induction/concurrent chemotherapy, chemoradiation and/or surgery [1][2][3][4][5].…”

mentioning

confidence: 99%

See 1 more Smart Citation

Survivorship Program Including Long-Term Toxicities and Quality-of-Life Development Over Ten Years within a Randomized Phase-III Trial in Operable Stage III Non-Small-Cell Lung Cancer (ESPATUE)

Schulte,

Gauler,

Pöttgen

et al. 2023

Preprint

View full text Add to dashboard Cite

Purpose Over 40% stage-III non-small-cell lung cancer patients experience five-year survival following multimodality treatment. Little is known about relevant late toxicities and quality-of-life (QoL) ten years from diagnosis. Methods We invited long-term follow-up-patients from our randomized phase-III trial (Eberhardt et al., Journal of Clinical Oncology 2015) to participate within a structured survivorship program (SSP) including follow-up imaging, laboratory parameters, cardio-pulmonary investigations and long-term toxicity evaluations. QoL questionnaires at 10-years were compared to baseline and early follow-up on exploratory basis. Results Of 246 patients included, 161 evaluated potentially resectable after induction were randomized to definitive chemoradiation boost (A; 80) or definitive surgery (B; 81) (85 not randomized (C)). 31 of 37 patients (OS > 10 yrs) agreed to the SSP (A:13, B:12, C:6). Significant long-term toxicities of 3°/4° were rarely observed (lung(FEV1) 3° A:0/9, B:1/6, C:0/5; 4° A:1/9, B:0/6, C:1/5; no 3°/4° cardiac toxicity, no 3°/4° chronic kidney disease, no 3°/4° polyneuropathy). A:5/12, B:1/10 and C:1/6 patients showed relevant nutritional disorders (obesity 3°). QoL analysis of both arms showed no relevant signals of worsening compared to earlier and baseline results. Mean QoL in SSP A: 56.41/100 pts., B: 64.39/100 pts., C: 59.72/100 pts. Conclusions Long-term surviving patients following definitive chemoradiation or surgery showed comparable long-term toxicities and QoL assessments. Most patients are in good clinical status. Implications for Cancer Survivors This is the first comprehensive SSP reported in stage-III NSCLC treated within a randomized multimodality trial and may serve as baseline information for physician and patient deciding for a treatment option.

show abstract

mentioning

confidence: 99%

mentioning

confidence: 99%

Survivorship Program Including Long-Term Toxicities and Quality-of-Life Development Over Ten Years within a Randomized Phase-III Trial in Operable Stage III Non-Small-Cell Lung Cancer (ESPATUE)

Schulte,

Gauler,

Pöttgen

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

Survivorship program including long‐term toxicities and quality‐of‐life development over 10 years in a randomized trial in operable stage III non‐small‐cell lung cancer (ESPATUE)

Schulte,

Gauler,

Pöttgen

et al. 2024

Intl Journal of Cancer

View full text Add to dashboard Cite

Over 40% stage‐III non‐small‐cell lung cancer (NSCLC) patients (pts) experience 5‐year survival following multimodality treatment. Nevertheless, little is known about relevant late toxicities and quality‐of‐life (QoL) in the further long‐term follow‐up. Therefore, we invited pts from our randomized phase‐III trial (Eberhardt et al., Journal of Clinical Oncology 2015) after 10 years from diagnosis to participate within a structured survivorship program (SSP) including follow‐up imaging, laboratory parameters, cardio‐pulmonary investigations, long‐term toxicity evaluations and QoL questionnaires. Of 246 pts initially accrued, 161 were considered potentially resectable following the induction therapy and were randomized (80 to arm A: definitive chemoradiation; 81 to arm B: definitive surgery; 85 not randomized for different reasons; group C). 31 from 37 pts still alive after 10 years agreed to the SSP (13 in A; 12 in B; 6 in C). Clinically relevant long‐term toxicities (grade 3 and 4) were rarely observed with no signal favoring any of the randomization arms. Furthermore, available data from the global QoL analysis did not show a signal favoring any definitive locoregional approach (Mean QoL in SSP A pts: 56.41/100, B pts: 64.39/100) and no late decline in comparison to baseline and early 1‐year follow‐up. This is the first comprehensive SSP of very late survival follow‐up reported in stage‐III NSCLC treated within a randomized multimodality trial and it may serve as important baseline information for physicians and pts deciding for a locoregional treatment option.

show abstract

Creation of an Integrated Clinical Trial Database and Data Sharing for Conducting New Research by the Japan Lung Cancer Society

Cited by 2 publications

References 35 publications

Survivorship Program Including Long-Term Toxicities and Quality-of-Life Development Over Ten Years within a Randomized Phase-III Trial in Operable Stage III Non-Small-Cell Lung Cancer (ESPATUE)

Survivorship Program Including Long-Term Toxicities and Quality-of-Life Development Over Ten Years within a Randomized Phase-III Trial in Operable Stage III Non-Small-Cell Lung Cancer (ESPATUE)

Survivorship program including long‐term toxicities and quality‐of‐life development over 10 years in a randomized trial in operable stage III non‐small‐cell lung cancer (ESPATUE)

Contact Info

Product

Resources

About