In December 2007, Ms. 54, who had aggravated hemoptysis for 2 months, lost weight, lost appetite, and had bone pain. A CT chest scan revealed a 9 cm x 5.8 cm x 7.2 cm “large, lobulated, heterogeneously enhanced mass” in the left lower lobe of the lung. In addition, another smaller needle-like lesion was found in the upper left lobe.
Later, biopsy confirmed invasive, moderately differentiated lung squamous cell carcinoma. A CT scan showed involvement of the chest wall muscles and had metastasized. Her bone scan was negative (no metastases). Therefore, she was diagnosed with T4N1M0-IIIb stage non-small cell lung cancer.
In 3 months, Ms. M was treated with paclitaxel (260 mg) and carboplatin (415 mg) for 3 cycles. This shrinks the tumor to 7 cm x 6 cm x 5 cm. Later, chemoradiotherapy was performed in parallel with 2 cycles of cisplatin (50 mg) and 60 Gy of radiation.
Two months after the completion of chemoradiotherapy, Ms. M learned that there was a clinical trial of a lung cancer vaccine and decided to receive CIMAvax vaccine after thinking about it.
80% of people who received cyclophosphamide treatment before CIMAvax injection showed some anti-EGF activity. Vaccination at multiple sites will further increase effectiveness.
A preoperative CT scan showed a 3 cm x 3 cm lesion in the lower lobe (Figure 1). Left upper lobe lesions were less than 1 cm in diameter, and localized pleural effusion was secondary to radiotherapy.
After 3 months of CIMAvax lung cancer vaccine treatment, the tumor shrank to 2 cm x 2.1 cm
By 6 months of treatment, the tumor had shrunk from its original volume by 30% to 1.5 cm x 2.3 cm before stabilization. At this time, her pleural effusion continued to decrease, and her local lymph nodes became smaller.
During the first 16 shots, Ms. M did not experience any side effects. Within minutes of the 17th injection, her waist pain had “ increased ” and was considered a vaccine-related Grade 3 response. Symptoms subsided after 10 minutes of treatment with 10 mg of chlorpheniramine, 200 mg of hydrocortisone and 50 mg of tramadol.
Later, she decided to stop treatment with the CIMAvax vaccine. A chest CT scan was performed three months after stopping treatment (18 months after starting CIMAvax treatment). Six months have passed since her last scan, and there has been no “significant change” in tumor size (Figure 3), and her condition has remained stable.
At the last follow-up-28 months after stopping the vaccination-the women’s FNM was in good condition and healthy and stable. Her ECOG status has remained at 0 (best). At this point, she has survived 48 months since her diagnosis and her condition remains stable.
Ms. M ’s lung cancer vaccine was approved for marketing in Cuba in 2008 for maintenance treatment of stage IIIB-IV non-surgical advanced non-small cell lung cancer (NSCLC). This is the first registration of a therapeutic vaccine in Cuba and the first registration of a lung cancer vaccine in the world.
