A pill or a shot? Chemotherapy options for locally advanced non-small cell lung cancer

This study examined the safety and effectiveness of oral vinorelbine (Navelbine), a new form of a standard chemotherapy treatment for stage 3 non-small cell lung cancer.

Because symptoms of early non-small cell lung cancer can be vague, many patients are not diagnosed until their disease is locally advanced (stage 3, or spread to the local lymph nodes). Patients with stages 3A (cancer has spread to lymph nodes near or on the same side of the chest) or 3B (cancer has spread to lymph nodes above the collarbone or on the opposite side of the chest) typically cannot have their tumors surgically removed (referred to as non-resectable), therefore platinum-based chemotherapy combined with radiotherapy is recommended.

The combination of two agents, vinorelbine and cisplatin (Platinol), delivered intravenously (injection directly into a vein), is one of the standard chemotherapy regimens used for patients with stage 3 non-small cell lung cancer. An oral version (taken by mouth) of vinorelbine, which may be a more convenient delivery system for patients, has been created, but a dosing schedule in combination with cisplatin has not yet been established.

The current study evaluated the safety and effectiveness of oral vinorelbine in combination with cisplatin and radiotherapy in patients with non-resectable stage 3 non-small cell lung cancer. In this study, 69 patients underwent two 3-week cycles of intravenous vinorelbine/cisplatin. Following this period, the 47 patients who saw a response to the chemotherapy or whose disease did not progress (patients whose disease progressed were removed from the study) received two more 3-week cycles with oral vinorelbine combined with cisplatin and radiotherapy. Patients were followed until their death or the end of the study, whichever came first.

The overall disease control rate (the number of patients showing any response or no progression following treatment) was 81.43%: 7.14% saw a complete response (no disease activity), 38.57% saw a partial response (decreasing tumor size), and 35.5% had no change in their disease.  Disease control continued in more than 50% of these patients at 19 months.

Average progression-free survival time (time before disease progressed) was 14.58 months. The progression-free survival rate was 58.6% at 12 months. The average overall survival rate (time until death from any cause) was 17.08 months, with an average 1-year survival rate of 68.6%, and a 2-year survival rate of 37%.

In the initial two cycles of intravenous chemotherapy, 8.6% of patients reported leucopenia (decrease in white blood cells, part of the immune system that fights off disease) and 24.3% reported neutropenia (low levels of neutrophils, a type of white blood cell), but the incidence of each decreased to 2% during the oral vinorelbine phase. 26.5% of patients reported esophagitis (swelling or irritation of the esophagus).

This study concluded that oral vinorelbine, when used in combination with cisplatin, is a safe and effective treatment for patients with non-resectable stage 3 non-small cell lung cancer.