Whereas only a few oral cytotoxics have been developed in the past and these have often been shown to be less efficient than their I.V. formulation, NAVELBINE^® Oral has been carefully compared to NAVELBINE^® I.V.:

• to establish dose correspondence between the two forms,
• to demonstrate similar activity, either as a single agent or in combination.

In clinical practice, the choice of oral chemotherapy is made in each individual case based on the patient’s characteristics, taking into account several considerations such as whether the patient is hospitalised or whether other drugs to be given concomitantly require I.V. administration. Appropriate patient selection is necessary to ensure that oral chemotherapy will meet the expectations of both the patient and the carer. (2) Choosing NAVELBINE^® Oral is making a choice both for NAVELBINE® and for oral chemotherapy. The choice of NAVELBINE^® relies firstly on its efficacy, well established both as a single agent and in combination with other major drugs, and on its tolerability. It also relies on the pharmacological equivalence between the two routes, I.V. and oral, which guarantees the efficacy and the tolerability of NAVELBINE^® Oral. Then, other criteria will affect the process of decision making.

 

Ease of administration

Oral chemotherapy avoids the need for cannulation, often a cause of anxiety and discomfort for patients. The flexibility of oral chemotherapy, which can be given in a number of settings such as the patient’s home, nursing home, outpatient clinic or hospital is a major advantage.

Less constraints for the patient

Oral chemotherapy reduces the constraints for patients as it is associated with shorter hospital stays, no need for permanent venous access and as a consequence less psychological distress. The reduced number of visits to hospital, particularly when long distance trips are required, avoids reduces the impact on their family, social or sometimes professional life

Preferred by most patients

Several studies have shown that a majority of patients prefer oral chemotherapy. A questionnaire was developed and pilot-tested in Italy (4). It revealed a positive view of oral chemotherapy by most women with breast cancer as it helps them feel less ill (77%) and reduces the effort in coping with the disease (67%). The most important feeling elicited was the sense of freedom. The reduced impact on daily life and social activities explains why this preference is particularly true in younger patients (<45 years) who are the ones who expect the most from oral chemotherapy.

Another study was conducted in Denmark in patients with lung cancer. After having experienced both formulations, 74% of patients preferred NAVELBINE^® Oral to its intravenous equivalent (5), even when combined with an intravenous infusion of carboplatin.

Cost benefits

The advantages lie in the reduced workload of the oncology clinic and savings from decreased costs of chemotherapy preparation and administration. These administration costs can include hospitalisation, infusion equipment and consumables, intravenous fluids, salaries… Time saved due to NAVELBINE^® Oral can be reallocated to other tasks or other patients, offering benefits that can improve the activity of the unit. (7)

Patient compliance

Although patient compliance to oral chemotherapy may be subject to variability, the key to success lies with comprehensive patient/carer education and continued monitoring of therapy.
NAVELBINE^® Oral offers several advantages for patient compliance: once weekly administration, simple regimens and safe packaging with one capsule per blister and one blister per box. A patient booklet has been specially designed to help the monitoring of therapy. It can be distributed to patients to help compliance with treatment and assist follow-up by the carer.

2) Gilbart et al : Journal of Pharmacy Practice and Research 2005 ; 35(3) : 195-198.
(3) Borner MM et al : Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin : a randomized crossover trial in advanced colorectal cancer. Eur. J. Can. 2002; 38: 349-358.
(4) Catania C et al : Perception that oral anticancer treatments are less efficacious : development of a questionnaire to assess the possible prejudices of patients with cancer. BCRT 2005; 92 : 265-272.
(5) Liu G et al : Patient preferences for oral versus intravenous palliative chemotherapy. J. Clin.Oncol. 1997 ; 15 : 110-115.
(6) Jensen LH et al. Randomized cross-over study of patient preference for oral or intravenous vinorelbine in combination with carboplatin in the treatment of advanced NSCLC. Lung Cancer 2008.
(7) Taylor H, Burcombe R, Hill S, et al Assessing the impact on staff resource and patient waiting time of a switch from I.V. to oral chemotherapy : time and motion model for HTAS. Proc. NCRI Cancer Conference 2005 abst. P435.