Tumor response to chemotherapy: The validity and reproducibility of RECIST guidelines in NSCLC patients¹

Abstract

We investigated the validity and inter-criteria reproducibility between RECIST (Response Evaluation Criteria in Solid Tumors) guidelines and WHO (World Health Organization) criteria, considering the decrease in patient numbers resulting from inclusion of the minimum lesion size criterion introduced in RECIST guidelines. RECIST guidelines are based on unidimensional measurement and exclusion of small lesions from measurement. The aims of the study were to examine: (1) the effect of the minimum lesion size criterion, (2) the validity of unidimensional and bidimensional measurements, i.e., their relationship with tumor volume, (3) the inter-criteria reproducibility between current RECIST guidelines and previous WHO criteria. One hundred and twenty patients with non-small cell lung cancer (NSCLC) in clinical trials were evaluated. By applying the minimum lesion size criterion, six cases became ineligible without any influence on precision of tumor volume measurement. In the validity study, actual tumor volume was regarded as the gold standard. Although the unidimensional measurement had a lower correlation with tumor volume value than the bidimensional measurement, both the unidimensional measurement and bidimensional measurement correlated sufficiently well with tumor volume changes and the assessed tumor volume response. In the inter-criteria reproducibility study between RECIST guidelines and WHO criteria, the response rate assessed by RECIST guidelines (19.3%) was almost the same as that assessed by WHO criteria (20.0%). In conclusion, RECIST guidelines are adequate for evaluating tumor response to chemotherapy in terms of both validity in relation to tumor volume and inter-criteria reproducibility with the WHO criteria. 2) and define the minimum lesion size allowable for measurability of the lesion to be no less than double the slice thickness on computed tomography (CT) or magnetic resonance imaging (MRI). When this minimum lesion size is included in the eligibility criteria, the number of patients with measurable lesions decreases in comparison to previous WHO criteria, because some patients with only small lesions are excluded from the eligibility criteria.Several previous studies have demonstrated the inter-measurement reproducibility between unidimensional and bidimensional measurement in the same cases.1, 3-5) However, they have not considered the decrease in number of eligible cases as a result of the inclusion of the minimum lesion size criterion, and thus they have been unable to demonstrate true inter-criteria reproducibility between RECIST guidelines and WHO criteria. In addition, validity has been based on the subjective theoretical inference that unidimensional measurement is more proportional to the logarithm of cell numbers than bidimensional measurement, but this hypothesis has not been objectively evaluated. 6)Before introducing RECIST guidelines at our institution, we considered that the validity and inter-criteria reproducibility between the new and conventional criteria should be investigate...

Pneumonectomy after chemoradiation

“…It has been previously reported that when surgery is used as an upfront treatment modality in patients with stage IIIA NSCLC, up to 30% of patients will have incomplete resection leaving behind macroscopic disease. 7 The 5-year survival rate for patients with incomplete resections is < 5%. [7][8][9][10] However, even in patients who can undergo complete resections, the risk of systemic disease is significant and the overall survival without adjuvant therapy at 5 years is only 10%.…”

“…7 The 5-year survival rate for patients with incomplete resections is < 5%. [7][8][9][10] However, even in patients who can undergo complete resections, the risk of systemic disease is significant and the overall survival without adjuvant therapy at 5 years is only 10%. 8 Furthermore, it is very difficult to administer adjuvant therapy after major surgery, with patient compliance limiting completion of adjuvant therapy.…”

A pharmaco-economic analysis of second-line treatment with imatinib or sunitinib in patients with advanced gastrointestinal stromal tumours

“…The investigation was conducted to determine the total cost an intervention would incur the IMSS per patient over the entire duration of second-line GIST treatment. Treatment costs were collected from the start of treatment until the documentation of tumour progression (Park et al, 2003;Watanabe et al, 2003). Further, patient data was investigated for a maximum of 5 years (referred to as the 5-year temporal horizon) so MC would be a true cost estimate of GIST care with a specific treatment.…”

Serum Anti-Gal-3 Autoantibody is a Predictive Marker of the Efficacy of Platinum-Based Chemotherapy against Pulmonary Adenocarcinoma

“…Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancers, and adenocarcinoma (AC) comprises about 50% of NSCLC (Jemal et al, 2007). Although platinum-based chemotherapy regimens improve the survival of patients with advanced NSCLC, resistance to chemotherapeutic agents is a major problem (Watanabe et al, 2003, Perng et al, 2008. In clinical practice, the chemotherapy response is variable among individuals.…”