Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Aug;149(9):6399-6409.
doi: 10.1007/s00432-023-04617-1. Epub 2023 Feb 9.

Improving the performance status in advanced non-small cell lung cancer patients with chemotherapy (ImPACt trial): a phase 2 study

Neha Pathak  1   2 , Rakesh Garg  3 , Sachin Khurana  1 , Sudhir Kumar  1   2 , Akash Kumar  1 , Deepam Pushpam  1 , Maroof Ahmad Khan  4 , Anant Mohan  5 , Sushmita Pathy  6 , Mukesh Yadav  7 , Chandra Prakash Prasad  1 , Prabhat Singh Malik  8
Affiliations
Clinical Trial

Improving the performance status in advanced non-small cell lung cancer patients with chemotherapy (ImPACt trial): a phase 2 study

Neha Pathak et al. J Cancer Res Clin Oncol. 2023 Aug.

Abstract

Purpose: This phase II trial is designed to test whether the performance status (PS) of metastatic non-small cell lung cancer (mNSCLC) patients (pts) can improve with chemotherapy if their poor PS (Eastern Cooperative Oncology Group (ECOG) PS of ≥ 2) is due to disease burden rather than comorbidities.

Methods: Age18-65 years, Charlson's comorbidity index < 9, serum albumin ≥ 3.5 g/dl, adequate bone marrow and organ function, & ECOG PS ≥ 2 as judged by the worst score of three independent physicians were administered 3 doses of weekly paclitaxel at 60 mg/m2/dose. The primary endpoint was an improvement in ECOG PS by 1 point at 4 weeks; others: toxicity (CTCAE v 5.0), quality of life (QoL) assessment at baseline and 4 weeks by EORTC QLQ-C30 and EORTC QLQ-LC13. Optimal Simon's 2-stage design was used.

Results: Forty-six patients were included with a median age of 56 years (interquartile range, IQR 54-59), 12 (26%) had comorbid conditions, and 87% with ECOG PS 3/4. PS improved in 11 pts at 4 weeks and in 7 beyond this time point. Grade 3/4 toxicities are seen in 20% (most common: anemia and diarrhea). At a median follow-up of 4.8 m (95% CI 3.27-14.9), the median progression-free survival and overall survival were 3.3 months (95% CI 2.36-5.6) and 6.8 months (95% CI 2.47-8.8), respectively. QoL improved for global QoL, role functioning, pain, dyspnea, insomnia, pain in the chest, pain in other parts, and worsened for alopecia and sore mouth.

Conclusions: Abbreviated chemotherapy is a useful, well-tolerated strategy in carefully selected poor PS mNSCLC patients that can improve PS and QoL.

Clinical trial: Clinical trial information: CTRI/2020/01/022617.

Keywords: Carcinoma; Chemotherapy; Non-small-cell lung; Paclitaxel; Poor performance status; Quality of life.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

The authors have no relevant financial or non-financial interests to disclose.

Figures

Fig. 1
Fig. 1
Study flow. CCI Charlson’s comorbidity index, CNS central nervous system, ECOG Eastern Cooperative Oncology Group, EGFR epidermal growth factor receptor, NSCLC non-small cell lung cancer, PS performance status
Fig. 2
Fig. 2
Improvement in Performance status. PS performance status
Fig. 3
Fig. 3
Violin plot of EORTC LC 13 questionnaire change at 4 weeks vs baseline
Fig. 4
Fig. 4
Violin plot of EORTC Q-C30 change at 4 weeks vs baseline
See this image and copyright information in PMC

References

    1. Ando M, Ando Y, Hasegawa Y et al (2001) Prognostic value of performance status assessed by patients themselves, nurses, and oncologists in advanced non-small cell lung cancer. Br J Cancer 85:1634–1639. 10.1054/bjoc.2001.2162 - PMC - PubMed
    1. Belani CP, Ramalingam S, Perry MC et al (2008) Randomized, phase III study of weekly paclitaxel in combination with carboplatin versus standard every-3-weeks administration of carboplatin and paclitaxel for patients with previously untreated advanced non–small-cell lung cancer. JCO 26:468–473. 10.1200/JCO.2007.13.1912 - PubMed
    1. Blagden SP, Charman SC, Sharples LD et al (2003) Performance status score: do patients and their oncologists agree? Br J Cancer 89:1022–1027. 10.1038/sj.bjc.6601231 - PMC - PubMed
    1. Bonomi P, Blumenthal G, Ferris AS et al (2018) Making lung cancer clinical trials more inclusive: recommendations for expanding eligibility criteria. J Thorac Oncol 13:748–751. 10.1016/j.jtho.2018.02.013 - PubMed
    1. Charlson ME, Pompei P, Ales KL, MacKenzie CR (1987) A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 40:373–383. 10.1016/0021-9681(87)90171-8 - PubMed

Publication types

LinkOut - more resources