CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer.

BACKGROUND: A phase I/II study and subsequent phase III study (MPACT) reported significant correlations between CA19-9 decreases and prolonged overall survival (OS) with nab-paclitaxel plus gemcitabine (nab-P + Gem) treatment for metastatic pancreatic cancer (MPC). CA19-9 changes at week 8 and potential associations with efficacy were investigated as part of an exploratory analysis in the MPACT trial. PATIENTS AND METHODS: Untreated patients with MPC (N = 861) received nab-P + Gem or Gem alone. CA19-9 was evaluated at baseline and every 8 weeks. RESULTS: Patients with baseline and week-8 CA19-9 measurements were analyzed (nab-P + Gem: 252; Gem: 202). In an analysis pooling the treatments, patients with any CA19-9 decline (80%) versus those without (20%) had improved OS (median 11.1 versus 8.0 months; P = 0.005). In the nab-P + Gem arm, patients with (n = 206) versus without (n = 46) any CA19-9 decrease at week 8 had a confirmed overall response rate (ORR) of 40% versus 13%, and a median OS of 13.2 versus 8.3 months (P = 0.001), respectively. In the Gem-alone arm, patients with (n = 159) versus without (n = 43) CA19-9 decrease at week 8 had a confirmed ORR of 15% versus 5%, and a median OS of 9.4 versus 7.1 months (P = 0.404), respectively. In the nab-P + Gem and Gem-alone arms, by week 8, 16% (40/252) and 6% (13/202) of patients, respectively, had an unconfirmed radiologic response (median OS 13.7 and 14.7 months, respectively), and 79% and 84% of patients, respectively, had stable disease (SD) (median OS 11.1 and 9 months, respectively). Patients with SD and any CA19-9 decrease (158/199 and 133/170) had a median OS of 13.2 and 9.4 months, respectively. CONCLUSION: This analysis demonstrated that, in patients with MPC, any CA19-9 decrease at week 8 can be an early marker for chemotherapy efficacy, including in those patients with SD. CA19-9 decrease identified more patients with survival benefit than radiologic response by week 8.

Mediastinal lymph-node biopsy is a definitive staging procedure for bronchogenic carcinoma.

Mediastinal lymph-node biopsy has been performed as a staging procedure in most cases of bronchogenic carcinoma since 1965. This study was carried out to assess the results of staging by this method in 75 patients. Biopsy sites were marked with hemoclips. Three zones were defined: zone 3 (inoperable), beyond the midline and above the lower border of the aortic arch; zone 1 (operable), more than 3 cm from the carcinoma, ipsilateral to the tumour; and zone 2, between zones 1 and 3. Forty of 75 patients had biopsy specimens showing carcinoma. The proportion was highest in small cell anaplastic carcinoma and lowest in squamous cell tumours. Of the 40 positive biopsies 35 were from zone 3. All the positive biopsy specimens showing small cell anaplastic carcinoma were from zone 3. Positive specimens correlated strongly with other evidence of inoperability. Mediastinal lymph-node biopsy is a definitive staging procedure.

The application of 67Ga scanning in determining the operability of bronchogenic carcinoma.

In a prospective study of 34 patients with histologically proven bronchogenic carcinoma, 67Ga scanning of the chest was used to screen for mediastinal involvement. Mediastinal scans and pathologic findings were in agreement in 27 patients. Two patients had false-negative scans and 5 had positive scans but no evidence of mediastinal tumor. These results indicate a sensitivity of 89%, a specificity of 66.6%, an accuracy of 77% for positive scans, and an accuracy of 83% for negative scans. Overall correlation between 67Ga scanning of the chest and mediastinal-tumor involvement is statistically significant (P = 0.003).