Non-Small-Cell Lung Cancer Metastatic, Spinal Metastases
Conditions
Keywords
Survival Prediction, Spinal Metastases, Non Small Cell Lung Cancer Metastatic
Brief summary
The purpose of this study is to learn whether our own made predictive algorithm can be used as a clinical practical decision support for patients with NSCLC spinal metastasis. The scoring system consists of the use of EGFR-TKI, KPS, Age, SCC, CA125 and smoking history. By predicting survival doctors could determine which patients are suitable for palliative therapy.
Detailed description
Investigators have performed a retrospective study on 176 patients with NSCLC spinal metastasis under the oversight of hospital's ethics committee, and investigators found that the use of EGFR-TKI, KPS, Age, SCC, CA125 and smoking history had significant association with survival. Then investigators built a simple, easy to use scoring system based on the features mentioned above. The score was calculated as 1 (for patients didn't receive EGFR-TKI), +2 (for KPS \<50%), +1 (for KPS 50-70%), +1 (Age \>60years), 2 (SCC ≥1.5ng/ml), +3 (CA125 ≥35 U/ml), +1 (smoking history 1-10/day), +2 (smoking history \>10/day), and 0 otherwise. This algorithm was used to divide the patients into low risk (0-3), intermediate risk (4-6), high risk groups (7-10) to predict survival and determine which patients are suitable for palliative therapy. Now investigators wish to register this study to do a further research, in order to verify the accuracy and sensitivity of this algorithm.
Interventions
None listed
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis by biopsy: Non-small-cell lung cancer, including non-squamous carcinoma and squamous cell carcinoma. * Diagnosis through both nucleotide bone scan and MRI or PET-CT: spinal metastasis. * Age 18-75 years. * Have been or is about to be treated according to NCCN panel recommendation.
Exclusion criteria
* Diagnosis by biopsy: other tumors. * Irregular follow-up and lost follow-up * Withdraw from the study for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual survival of NSCLC spinal metastasis patients from 3 different risk groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Markers | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | Differences in the serum markers after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups. |
| Visceral Metastasis | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | The correlation between visceral metastasis and overall survival (OS) of NSCLC spinal metastasis patients |
| Visual Analogue Scale (VAS) | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | Assessment of pain level (1-10, higher value represents more pain) |
| Primary and Metastatic Lesions | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | Differences in the primary and metastatic lesions after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups. |
| EORTC Quality of Life Questionnaire (QLQ) Bone metastasis (BM) 22, | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | Assessment of quality of life (22-88, higher value represents worse quality of life) |
| Modified Frankel grade | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | Assessment of neurological function (A-E, higher value represents better function) |
| The Spinal Instability Neoplastic Score (SINS) | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | Assessment of spinal instability (0-18, higher value represents worse instability) |
| Ambulatory Status | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | Assessment of walking ability |
Countries
China
Outcome results
None listed